Neoplasms, ProstatePhase 3REDUCENCT00056407
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
A Phase 3 study testing Dutasteride in people with Neoplasms, Prostate, run by GlaxoSmithKline at 932 sites in 43 countries.
Trial summary
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Neoplasms, Prostate
- What is being tested?
- Dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,231 participants
- Where
- 932 sitesin 43 countries
- Study dates
- Mar 2003to Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent to participate in study.
- Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
- Ability and will to participate in study for 4 years.
Who cannot join
- More than one previous negative prostate biopsy.
- History of prostate cancer.
- Previous prostate surgery.
- Inability to urinate requiring the need of a catheter during the previous 2 years.
- Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
- Cancer within previous 5 years (other than basal or squamous cell cancers of the skin).
- Any unstable serious medical condition.
- Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride (Avodart), testosterone, or drugs that can block the action of male hormones.
Trial locations and contacts
932 sites in 43 countries.
932 sites in 43 countries
United States297 sites
GSK Investigational Site
Albany, New York, 12208
GSK Investigational Site
Alexandria, Virginia, 22302
GSK Investigational Site
Amarillo, Texas, 79106
GSK Investigational Site
Anaheim, California, 92801
GSK Investigational Site
Anchorage, Alaska, 99508
GSK Investigational Site
Ann Arbor, Michigan, 48106
GSK Investigational Site
Annapolis, Maryland, 21401
GSK Investigational Site
Arlington, Texas, 76017
GSK Investigational Site
Atherton, California, 94027
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Aurora, Colorado, 80010
GSK Investigational Site
Aurora, Colorado, 80012
GSK Investigational Site
Austin, Texas, 78757
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Binghamton, New York, 13901
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Bismarck, North Dakota, 58501
GSK Investigational Site
Boston, Massachusetts, 02115
GSK Investigational Site
Braintree, Massachusetts, 02184
GSK Investigational Site
Brooklyn, New York, 11234
GSK Investigational Site
Bryn Mawr, Pennsylvania, 19010
GSK Investigational Site
Camp Hill, Pennsylvania, 17011
GSK Investigational Site
Cary, North Carolina, 27511
GSK Investigational Site
Cary, North Carolina, 27518
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7600
GSK Investigational Site
Charleston, South Carolina, 29425
GSK Investigational Site
Charlotte, North Carolina, 28211
GSK Investigational Site
Charlotte, North Carolina, 28262
GSK Investigational Site
Charlotte, NC 28207, North Carolina, 28207
GSK Investigational Site
Charlottesville, Virginia, 22911
GSK Investigational Site
Chaska, Minnesota, 55318
GSK Investigational Site
Cheyenne, Wyoming, 82001
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60616
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Chicago, Illinois, 60640
GSK Investigational Site
Cincinnati, Ohio, 45212
GSK Investigational Site
Cincinnati, Ohio, 45219
GSK Investigational Site
Clearwater, Florida, 33756
GSK Investigational Site
Clearwater, Florida, 33761
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Columbus, Ohio, 43214
GSK Investigational Site
Columbus, Ohio, 43220
GSK Investigational Site
Columbus, Ohio, 43235
GSK Investigational Site
Concord, North Carolina, 28025
GSK Investigational Site
Covington, Louisiana, 70433
GSK Investigational Site
Cranston, Rhode Island, 02920
GSK Investigational Site
Culver City, California, 90232
GSK Investigational Site
Dallas, Texas, 75216
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Dallas, Texas, 75234
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Delray Beach, Florida, 33484
GSK Investigational Site
Denver, Colorado, 80211
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
East Syracuse, New York, 13057
GSK Investigational Site
Edina, Minnesota, 55435
GSK Investigational Site
Edison, New Jersey, 08837
GSK Investigational Site
Elmont, New York, 11003
GSK Investigational Site
Elyria, Ohio, 44035
GSK Investigational Site
Encino, California, 91316
GSK Investigational Site
Endwell, New York, 13760
GSK Investigational Site
Englewood, Colorado, 80113
GSK Investigational Site
Evansville, Indiana, 47714
GSK Investigational Site
Fairfax, Virginia, 22031
GSK Investigational Site
Fayetteville, Georgia, 30214
GSK Investigational Site
Fort Myers, Florida, 33916
GSK Investigational Site
Fort Pierre, South Dakota, 57501
GSK Investigational Site
Fort Wayne, Indiana, 46825
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Galesburg, Illinois, 61401
GSK Investigational Site
Garden City, New York, 11530
GSK Investigational Site
Germantown, Tennessee, 38138
GSK Investigational Site
Graham, Washington, 98338
GSK Investigational Site
Great Neck, New York, 11021
GSK Investigational Site
Greenbelt, Maryland, 20770
GSK Investigational Site
Greensboro, North Carolina, 27403
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Greenville, South Carolina, 29650
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Gretna, Louisiana, 70056
GSK Investigational Site
Hackensack, New Jersey, 07601
GSK Investigational Site
Harrisburg, Pennsylvania, 17110
GSK Investigational Site
Harrisonburg, Virginia, 22801
GSK Investigational Site
Hartford, Connecticut, 06106
GSK Investigational Site
Hattiesburg, Mississippi, 39401
GSK Investigational Site
Haverhill, Massachusetts, 01830
GSK Investigational Site
Henderson, Nevada, 89014
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850
GSK Investigational Site
Homewood, Alabama, 35209
GSK Investigational Site
Honolulu, Hawaii, 96813
GSK Investigational Site
Houma, Louisiana, 70360
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Huntsville, Alabama, 35801
GSK Investigational Site
Indianapolis, Indiana, 46202
GSK Investigational Site
Irvine, California, 92618
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Jacksonville, Florida, 32216
GSK Investigational Site
Jacksonville, Florida, 32224
GSK Investigational Site
Jacksonville, Florida, 32257
GSK Investigational Site
Jeffersonville, Indiana, 47130
GSK Investigational Site
Kankakee, Illinois, 60901
GSK Investigational Site
Kansas City, Kansas, 66160
GSK Investigational Site
Kansas City, Missouri, 64114
GSK Investigational Site
Kettering, Ohio, 45429
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
La Mesa, California, 91942
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Laguna Hills, California, 92653
GSK Investigational Site
Lake Worth, Florida, 33461
GSK Investigational Site
Lancaster, Pennsylvania, 17601
GSK Investigational Site
Lancaster, Pennsylvania, 17604
GSK Investigational Site
Largo, Florida, 33773
GSK Investigational Site
Las Vegas, Nevada, 89106
GSK Investigational Site
Las Vegas, Nevada, 89148
GSK Investigational Site
Lawrencevill, New Jersey, 08648
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Lexington, Kentucky, 40508
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Little Rock, Arkansas, 72211
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Longmont, Colorado, 80501
GSK Investigational Site
Longwood, Florida, 32750
GSK Investigational Site
Los Angeles, California, 90024
GSK Investigational Site
Los Angeles, California, 90033
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Los Angeles, California, 90059
GSK Investigational Site
Los Angeles, California, 90073
GSK Investigational Site
Madison, Wisconsin, 53715
GSK Investigational Site
Margate, Florida, 33063
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Marion, Ohio, 43302
GSK Investigational Site
Marlton, New Jersey, 08053
GSK Investigational Site
Mather, California, 95655
GSK Investigational Site
Maywood, Illinois, 60153
GSK Investigational Site
Mechanicsville, Virginia, 23116
GSK Investigational Site
Melbourne, Florida, 32901
GSK Investigational Site
Melrose Park, Illinois, 60160
GSK Investigational Site
Memphis, Tennessee, 38119
GSK Investigational Site
Metairie, Louisiana, 70001
GSK Investigational Site
Miami, Florida, 33156
GSK Investigational Site
Middlebury, Connecticut, 06762
GSK Investigational Site
Milford, Massachusetts, 01757
GSK Investigational Site
Milwaukee, Wisconsin, 53209
GSK Investigational Site
Milwaukee, Wisconsin, 53215
GSK Investigational Site
Mineola, New York, 11501
GSK Investigational Site
Minneapolis, Minnesota, 55404
GSK Investigational Site
Mobile, Alabama, 36608
GSK Investigational Site
Monroeville, Pennsylvania, 15146
GSK Investigational Site
Myrtle Beach, South Carolina, 29572
GSK Investigational Site
Nashville, Tennessee, 37209
GSK Investigational Site
Nashville, Tennessee, 37232-2765
GSK Investigational Site
New Britain, Connecticut, 06052
GSK Investigational Site
New Orleans, Louisiana, 70115
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
New Orleans, Louisiana, 70121
GSK Investigational Site
New Port Richey, Florida, 34652
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
New York, New York, 10021
GSK Investigational Site
Newport Beach, California, 92660
GSK Investigational Site
Newton, Massachusetts, 2462
GSK Investigational Site
Newton, Pennsylvania, 18940
GSK Investigational Site
Niles, Illinois, 60714
GSK Investigational Site
Norfolk, Virginia, 23502
GSK Investigational Site
Ocala, Florida, 34471
GSK Investigational Site
Ocala, Florida, 34474
GSK Investigational Site
Okeechobee, Florida, 34972
GSK Investigational Site
Oklahoma City, Oklahoma, 73112
GSK Investigational Site
Omaha, Nebraska, 68114
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Orange, California, 92869
GSK Investigational Site
Orange Park, Florida, 32073
GSK Investigational Site
Orchard Park, New York, 14127
GSK Investigational Site
Oregon City, Oregon, 97045
GSK Investigational Site
Orlando, Florida, 32803
GSK Investigational Site
Overland Park, Kansas, 66211
GSK Investigational Site
Owings Mills, Maryland, 21117
GSK Investigational Site
Panama City, Florida, 32405
GSK Investigational Site
Perth Amboy, New Jersey, 08861
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19141
GSK Investigational Site
Philadelphia, Pennsylvania, 19144
GSK Investigational Site
Philadelphia, Pennsylvania, 19152
GSK Investigational Site
Phoenix, Arizona, 85014
GSK Investigational Site
Phoenix, Arizona, 85023
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Pico Rivera, California, 90660
GSK Investigational Site
Pittsburgh, Pennsylvania, 15215
GSK Investigational Site
Pittsburgh, Pennsylvania, 15232
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Poca City, Oklahoma, 74601
GSK Investigational Site
Portland, Oregon, 97205
GSK Investigational Site
Portland, Oregon, 97210
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Poughkeepsie, New York, 12601
GSK Investigational Site
Poway, California, 92064
GSK Investigational Site
Providence, Rhode Island, 02904
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Reno, Nevada, 89502
GSK Investigational Site
Reno, Nevada, 89511
GSK Investigational Site
Richmond, Virginia, 23249
GSK Investigational Site
Rochester, Minnesota, 55905
GSK Investigational Site
Rochester, New York, 14642
GSK Investigational Site
Rockville, Maryland, 20850
GSK Investigational Site
Rosemont, Pennsylvania, 19010
GSK Investigational Site
Roswell, Georgia, 30076
GSK Investigational Site
Royal Oak, Michigan, 48073
GSK Investigational Site
Ruston, Louisiana, 71270
GSK Investigational Site
Sacramento, California, 95816
GSK Investigational Site
Saint Cloud, Minnesota, 56303
GSK Investigational Site
Saint Joseph, Michigan, 49085
GSK Investigational Site
Salem, Virginia, 24153
GSK Investigational Site
Salinas, California, 93901
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Bernardino, California, 92404
GSK Investigational Site
San Diego, California, 92103-6204
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92128
GSK Investigational Site
San Francisco, California, 94108
GSK Investigational Site
San Francisco, California, 94121
GSK Investigational Site
San Ramon, California, 94583
GSK Investigational Site
Santa Monica, California, 90404
GSK Investigational Site
Sarasota, Florida, 34237
GSK Investigational Site
Scottsdale, Arizona, 85258
GSK Investigational Site
Seattle, Washington, 98101
GSK Investigational Site
Seattle, Washington, 98122
GSK Investigational Site
Seattle, Washington, 98133
GSK Investigational Site
Seattle, Washington, 98166
GSK Investigational Site
Seattle, Washington, 98195
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
Shreveport, Louisiana, 71106
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
South Daytona, Florida, 32119
GSK Investigational Site
Spokane, Washington, 99202
GSK Investigational Site
Springfield, Illinois, 62781
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
Springfield, Missouri, 65807
GSK Investigational Site
Springfield, Oregon, 97477
GSK Investigational Site
St Louis, Missouri, 63110-2539
GSK Investigational Site
St Louis, Missouri, 63136
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
St. Petersburg, Florida, 33703
GSK Investigational Site
Stanford, California, 94305
GSK Investigational Site
State College, Pennsylvania, 16801
GSK Investigational Site
Staten Island, New York, 10304
GSK Investigational Site
Stuart, Florida, 34996
GSK Investigational Site
Sun City, Arizona, 85375
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tacoma, Washington, 98431
GSK Investigational Site
Tacoma, Washington, 98499
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Temecula, California, 92591
GSK Investigational Site
Texarkana, Texas, 75503
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Torrance, California, 90505
GSK Investigational Site
Towson, Maryland, 21204
GSK Investigational Site
Trumbull, Connecticut, 06611
GSK Investigational Site
Tucson, Arizona, 85710
GSK Investigational Site
Tucson, Arizona, 85712
GSK Investigational Site
Tulsa, Oklahoma, 74146
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Van Nuys, California, 91405
GSK Investigational Site
Virginia Beach, Virginia, 23454
GSK Investigational Site
Voorhees Township, New Jersey, 08043
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Waltham, Massachusetts, 02453
GSK Investigational Site
Washington D.C., District of Columbia, 20307-5001
GSK Investigational Site
Watertown, Massachusetts, 02472
GSK Investigational Site
West Orange, New Jersey, 07052
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
West Warwick, Rhode Island, 02893
GSK Investigational Site
West Yarmouth, Massachusetts, 02673
GSK Investigational Site
Westchester, California, 90045
GSK Investigational Site
Wichita, Kansas, 67208
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Wocester, Massachusetts, 01608
GSK Investigational Site
Woodstock, Georgia, 30189
GSK Investigational Site
Zanesville, Ohio, 43701
Germany191 sites
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52078
GSK Investigational Site
Ahrensburg, Schleswig-Holstein, 22926
GSK Investigational Site
Aichach, Bavaria, 86551
GSK Investigational Site
Arnsberg, North Rhine-Westphalia, 59821
GSK Investigational Site
Augsburg, Bavaria, 86156
GSK Investigational Site
Backnang, Baden-Wurttemberg, 71522
GSK Investigational Site
Bad Bergzaben, Rhineland-Palatinate, 76887
GSK Investigational Site
Bad Doberan, Mecklenburg-Vorpommern, 18209
GSK Investigational Site
Bad Ems, Rhineland-Palatinate, 56130
GSK Investigational Site
Bad Griesbach, Bavaria, 94086
GSK Investigational Site
Bad Homburg, Hesse, 61348
GSK Investigational Site
Bad Schlema, Saxony, 08301
GSK Investigational Site
Bad Schönborn, Baden-Wurttemberg, 76669
GSK Investigational Site
Bad Schwartau, Schleswig-Holstein, 23611
GSK Investigational Site
Bamberg, Bavaria, 96047
GSK Investigational Site
Bautzen, Saxony, 02625
GSK Investigational Site
Berlin, State of Berlin, 10117
GSK Investigational Site
Berlin, State of Berlin, 10249
GSK Investigational Site
Berlin, State of Berlin, 10365
GSK Investigational Site
Berlin, State of Berlin, 10369
GSK Investigational Site
Berlin, State of Berlin, 10713
GSK Investigational Site
Berlin, State of Berlin, 10719
GSK Investigational Site
Berlin, State of Berlin, 10787
GSK Investigational Site
Berlin, State of Berlin, 12099
GSK Investigational Site
Berlin, State of Berlin, 12107
GSK Investigational Site
Berlin, State of Berlin, 12627
GSK Investigational Site
Berlin, State of Berlin, 12687
GSK Investigational Site
Berlin, State of Berlin, 13187
GSK Investigational Site
Berlin, State of Berlin, 13507
GSK Investigational Site
Berlin, State of Berlin, 14057
GSK Investigational Site
Bocholt, North Rhine-Westphalia, 46399
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53177
GSK Investigational Site
Borken, North Rhine-Westphalia, 46325
GSK Investigational Site
Braunschweig, Lower Saxony, 38100
GSK Investigational Site
Braunschweig, Lower Saxony, 38120
GSK Investigational Site
Bremervörde, Lower Saxony, 27432
GSK Investigational Site
Bruchsal, Baden-Wurttemberg, 76646
GSK Investigational Site
Buchholz, Lower Saxony, 21244
GSK Investigational Site
Buxtehude, Lower Saxony, 21614
GSK Investigational Site
Chemnitz, Saxony, 09119
GSK Investigational Site
Chemnitz, Saxony, 09126
GSK Investigational Site
Cologne, North Rhine-Westphalia, 50969
GSK Investigational Site
Dachau, Bavaria, 85221
GSK Investigational Site
Dessau, Saxony-Anhalt, 06842
GSK Investigational Site
Dessau, Saxony-Anhalt, 06844
GSK Investigational Site
Dierdorf, Rhineland-Palatinate, 56269
GSK Investigational Site
Döbeln, Saxony, 04720
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Dresden, Saxony, 01324
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47051
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47179
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47198
GSK Investigational Site
Dülmen, North Rhine-Westphalia, 48249
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40211
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40229
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40470
GSK Investigational Site
Ebersberg, Bavaria, 85560
GSK Investigational Site
Eisleben Lutherstadt, Saxony-Anhalt, 06295
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699
GSK Investigational Site
Essen, North Rhine-Westphalia, 45127
GSK Investigational Site
Essen, North Rhine-Westphalia, 45130
GSK Investigational Site
Esslingen am Neckar, Baden-Wurttemberg, 73728
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Forchheim, Bavaria, 91301
GSK Investigational Site
Frankfurt am Main, Hesse, 60326
GSK Investigational Site
Frankfurt am Main, Hesse, 60594
GSK Investigational Site
Frankfurt am Main, Hesse, 65929
GSK Investigational Site
Frankfurt am Main, Hesse, 65933
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Fürth, Bavaria, 90762
GSK Investigational Site
Ganderkesee, Lower Saxony, 27777
GSK Investigational Site
Gardelegen, Saxony-Anhalt, 39638
GSK Investigational Site
Garmisch-Partenkirchen, Bavaria, 82467
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45883
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45894
GSK Investigational Site
Gera, Thuringia, 07546
GSK Investigational Site
Gotha, Thuringia, 99867
GSK Investigational Site
Göttingen, Lower Saxony, 37073
GSK Investigational Site
Grimma, Saxony, 04668
GSK Investigational Site
Günzburg, Bavaria, 89312
GSK Investigational Site
Hagenow, Brandenburg, 19230
GSK Investigational Site
Halle, Saxony-Anhalt, 06132
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 21029
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22299
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22303
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22459
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22587
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22767
GSK Investigational Site
Hemmoor, Schleswig-Holstein, 21745
GSK Investigational Site
Hennigsdorf, Brandenburg, 16761
GSK Investigational Site
Herzogenaurach, Bavaria, 91074
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333
GSK Investigational Site
Hildesheim, Lower Saxony, 31134
GSK Investigational Site
Höchberg, Bavaria, 97204
GSK Investigational Site
Hochheim am Main, Hesse, 65239
GSK Investigational Site
Holzminden, Lower Saxony, 37603
GSK Investigational Site
Homburg, Saarland, 66424
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Ilmenau, Thuringia, 98693
GSK Investigational Site
Itzehoe, Schleswig-Holstein, 25524
GSK Investigational Site
Kamp-Lintfort, North Rhine-Westphalia, 47475
GSK Investigational Site
Kelheim, Bavaria, 93309
GSK Investigational Site
Kelkheim, Hesse, 65779
GSK Investigational Site
Kempen, North Rhine-Westphalia, 47906
GSK Investigational Site
Kiel, Schleswig-Holstein, 24143
GSK Investigational Site
Kleinblittersdorf, Baden-Wurttemberg, 66271
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Königsbrunn, Bavaria, 86343
GSK Investigational Site
Königswinter, North Rhine-Westphalia, 53639
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47799
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47805
GSK Investigational Site
Langenfeld, North Rhine-Westphalia, 40764
GSK Investigational Site
Lauenburg, Schleswig-Holstein, 21481
GSK Investigational Site
Leer, Lower Saxony, 26789
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Leipzig, Saxony, 04105
GSK Investigational Site
Leipzig, Saxony, 04109
GSK Investigational Site
Leipzig, Saxony, 04179
GSK Investigational Site
Leipzig, Saxony, 04229
GSK Investigational Site
Leuna, Saxony-Anhalt, 06237
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23562
GSK Investigational Site
Ludwigslust, Mecklenburg-Vorpommern, 19288
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68307
GSK Investigational Site
Marburg, Hesse, 35039
GSK Investigational Site
Markkleeberg, Saxony, 04416
GSK Investigational Site
Marl, North Rhine-Westphalia, 45770
GSK Investigational Site
Meiningen, Thuringia, 98617
GSK Investigational Site
Moers, North Rhine-Westphalia, 47445
GSK Investigational Site
Mülheim, North Rhine-Westphalia, 45475
GSK Investigational Site
Munich, Bavaria, 80336
GSK Investigational Site
Munich, Bavaria, 80539
GSK Investigational Site
Munich, Bavaria, 81927
GSK Investigational Site
Naumburg, Saxony-Anhalt, 06618
GSK Investigational Site
Neckargemünd, Baden-Wurttemberg, 69151
GSK Investigational Site
Neumarkt in der Oberpfalz, Bavaria, 92318
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534
GSK Investigational Site
Neustadt, Hesse, 67434
GSK Investigational Site
Neustadt, Saxony, 01844
GSK Investigational Site
Nieder-Olm, Rhineland-Palatinate, 55268
GSK Investigational Site
Nuremberg, Bavaria, 90402
GSK Investigational Site
Nuremberg, Bavaria, 90441
GSK Investigational Site
Nuremberg, Bavaria, 90482
GSK Investigational Site
Nuremberg, Bavaria, 90489
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46045
GSK Investigational Site
Oelsnitz, Saxony, 08606
GSK Investigational Site
Offenbach, Hesse, 63067
GSK Investigational Site
Oranienburg, Brandenburg, 16515
GSK Investigational Site
Ostfildern, Baden-Wurttemberg, 73760
GSK Investigational Site
Paderborn, North Rhine-Westphalia, 33098
GSK Investigational Site
Pirna, Saxony, 01796
GSK Investigational Site
Planegg, Bavaria, 82152
GSK Investigational Site
Plauen, Saxony, 08523
GSK Investigational Site
Plön, Schleswig-Holstein, 24306
GSK Investigational Site
Pulheim, North Rhine-Westphalia, 50259
GSK Investigational Site
Radebeul, Saxony, 01445
GSK Investigational Site
Rheinfelden, Baden-Wurttemberg, 79618
GSK Investigational Site
Ribnitz-Damgarten, Mecklenburg-Vorpommern, 18311
GSK Investigational Site
Rosenheim, Bavaria, 83022
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18069
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109
GSK Investigational Site
Roth, Bavaria, 91154
GSK Investigational Site
Salzgitter, Lower Saxony, 38226
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837
GSK Investigational Site
Schwarzenberg, Saxony, 08340
GSK Investigational Site
Schwedt, Brandenburg, 16303
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19053
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19057
GSK Investigational Site
Seligenstadt, Hesse, 63500
GSK Investigational Site
Senftenberg, Brandenburg, 01968
GSK Investigational Site
Starnberg, Bavaria, 82310
GSK Investigational Site
Starnberg, Bavaria, 82319
GSK Investigational Site
Strausberg, Brandenburg, 15344
GSK Investigational Site
Vellmar, Hesse, 34246
GSK Investigational Site
Waldkirch, Baden-Wurttemberg, 79183
GSK Investigational Site
Waltershausen, Thuringia, 99880
GSK Investigational Site
Wedel, Free and Hanseatic City of Hamburg, 22880
GSK Investigational Site
Weiden, Bavaria, 92637
GSK Investigational Site
Weißenburg in Bayern, Bavaria, 91781
GSK Investigational Site
Weißenfels, Saxony-Anhalt, 06667
GSK Investigational Site
Wertheim, Bavaria, 97877
GSK Investigational Site
Wesseling, North Rhine-Westphalia, 50389
GSK Investigational Site
Wiesbaden, Hesse, 65185
GSK Investigational Site
Wilkau-Haßlau, Saxony, 08112
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, 23970
GSK Investigational Site
Wolfsburg, Lower Saxony, 38440
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326
GSK Investigational Site
Wuppertal, North Rhine-Westphalia, 42103
GSK Investigational Site
Zwickau, Saxony, 08060
France54 sites
GSK Investigational Site
Amiens, 80094
GSK Investigational Site
Arcachon, 33120
GSK Investigational Site
Auch, 32000
GSK Investigational Site
Besançon, 25030
GSK Investigational Site
Bois-Bernard, 62320
GSK Investigational Site
Bordeaux, 33073
GSK Investigational Site
Boujan-sur-Libron, 34760
GSK Investigational Site
Cabestany, 66330
GSK Investigational Site
Caen, 14050
GSK Investigational Site
Cannes, 06400
GSK Investigational Site
Carpentras, 84200
GSK Investigational Site
Chalon-sur-Saône, 71100
GSK Investigational Site
Châlons-en-Champagne, 51000
GSK Investigational Site
Cholet, 49300
GSK Investigational Site
Créteil, 94010
GSK Investigational Site
Dijon, 21000
GSK Investigational Site
Domarin, 38300
GSK Investigational Site
Dunkirk, 59240
GSK Investigational Site
Fourmies, 59611
GSK Investigational Site
Grande-Synthe, 59760
GSK Investigational Site
Guilherand-Granges, 07500
GSK Investigational Site
Le Havre, 76600
GSK Investigational Site
Le Raincy, 93340
GSK Investigational Site
Lille, 59037
GSK Investigational Site
Longjumeau, 91161
GSK Investigational Site
Lyon, 69437
GSK Investigational Site
Marseille, 13008
GSK Investigational Site
Marseille, 13274
GSK Investigational Site
Montauban, 82000
GSK Investigational Site
Montpellier, 34000
GSK Investigational Site
Nîmes, 30900
GSK Investigational Site
Orléans, 45100
GSK Investigational Site
Orsay, 91401
GSK Investigational Site
Paris, 75475
GSK Investigational Site
Paris, 75877
GSK Investigational Site
Pau, 64000
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Ploemeur, 56270
GSK Investigational Site
Poitiers, 86021
GSK Investigational Site
Reims, 51100
GSK Investigational Site
Rouen, 76000
GSK Investigational Site
Saint-Cyr-sur-Loire, 37540
GSK Investigational Site
Saint-Etienne, 42000
GSK Investigational Site
Saint-Etienne, 42013
GSK Investigational Site
Saint-Grégoire, 35760
GSK Investigational Site
Saint-Martin-d'Hères, 38400
GSK Investigational Site
Saint-Nazaire, 44600
GSK Investigational Site
Saint-Quentin, 02321
GSK Investigational Site
Suresnes, 92151
GSK Investigational Site
Toulouse, 31403
GSK Investigational Site
Tours, 37000
GSK Investigational Site
Tours, 37044
GSK Investigational Site
Troyes, 10000
GSK Investigational Site
Vannes, 56000
United Kingdom49 sites
GSK Investigational Site
Aberdeen, Aberdeenshire, AB25 2ZD
GSK Investigational Site
Ayr, Ayrshire, KA6 6DX
GSK Investigational Site
Bath, Somerset, BA1 1BX
GSK Investigational Site
Birmingham, Warwickshire, B9 5SS
GSK Investigational Site
Bradford, BD5 0NA
GSK Investigational Site
Bristol, Gloucestershire, BS10 5NB
GSK Investigational Site
Bristol, BS2 8HW
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA
GSK Investigational Site
Cardiff, Glamorgan, CF14 5GJ
GSK Investigational Site
Chichester, Sussex West, PO19 4SE
GSK Investigational Site
Clydebank, Glasgow, G81 2DR
GSK Investigational Site
Coventry, Warwickshire, CV1 2TZ
GSK Investigational Site
Crewe, CW1 4QJ
GSK Investigational Site
Edgbaston, Birmingham, B15 2SQ
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU
GSK Investigational Site
Exeter, Devon, EX2 5DW
GSK Investigational Site
Falkirk, FK1 5QE
GSK Investigational Site
Glasgow, Lanarkshire, G51 4TF
GSK Investigational Site
Lancs, Lancashire, PR7 1PP
GSK Investigational Site
Leeds, LS9 7TF
GSK Investigational Site
Leicester, Leicestershire, LE5 4PW
GSK Investigational Site
Leytonstone, London, E11 1NR
GSK Investigational Site
Liverpool, Merseyside, L1 9AD
GSK Investigational Site
Liverpool, Merseyside, L7 8XP
GSK Investigational Site
London, EC1 7BE
GSK Investigational Site
London, NW3 2QG
GSK Investigational Site
London, SW17 0QT
GSK Investigational Site
London, W1P 7PN
GSK Investigational Site
Manchester, Lancashire, M41 5SL
GSK Investigational Site
Manchester, Lancashire, M8 5RB
GSK Investigational Site
Manchester, M15 6SX
GSK Investigational Site
Newcastle upon Tyne, Northumberland, NE7 7DN
GSK Investigational Site
Norwich, Norfolk, NR4 7FP
GSK Investigational Site
Nottingham, Nottinghamshire, NG5 1PB
GSK Investigational Site
Oldham, Lancashire, OL1 2JH
GSK Investigational Site
Plymouth, Devon, PL6 8DH
GSK Investigational Site
Portsmouth, Hampshire, PO3 6AD
GSK Investigational Site
Reading, Berkshire, RG2 0TG
GSK Investigational Site
Redhill, Surrey, RH1 5RH
GSK Investigational Site
Sheffield, S10 2JF
GSK Investigational Site
Southampton, Hampshire, SO16 6YD
GSK Investigational Site
Stevenage, Hertfordshire, SG2 4AB
GSK Investigational Site
Stockport, Cheshire, SK2 7JE
GSK Investigational Site
Stoke-on-Trent, Staffordshire, ST4 6QG
GSK Investigational Site
Tauton, Somerset, TA1 5DA
GSK Investigational Site
Torquay, TQ2 7AA
GSK Investigational Site
Wakefield, WF1 4DG
GSK Investigational Site
Waterloo, Liverpool, L22 0LG
GSK Investigational Site
Wolverhampton, WV10 9RU
Spain47 sites
GSK Investigational Site
Alava, 01004
GSK Investigational Site
Alcala de Henares (Madrid)
GSK Investigational Site
Alcorcón, 28922
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Barcelona, 08003
GSK Investigational Site
Barcelona, 08024
GSK Investigational Site
Barcelona, 08025
GSK Investigational Site
Barcelona, 08035
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Barcelona, 8907
GSK Investigational Site
Bilbao, 48013
GSK Investigational Site
Castellon, 12004
GSK Investigational Site
Ciudad Real, 13600
GSK Investigational Site
Don Benito (Badajoz), 06400
GSK Investigational Site
Donostia / San Sebastian, 20014
GSK Investigational Site
Galdakano, 48960
GSK Investigational Site
Granada, 18012
GSK Investigational Site
Ibiza Town, 07800
GSK Investigational Site
Jaén, 27007
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), 38320
GSK Investigational Site
Leganés
GSK Investigational Site
Logroño, 26006
GSK Investigational Site
Madrid, 28003
GSK Investigational Site
Madrid, 28006
GSK Investigational Site
Madrid, 28007
GSK Investigational Site
Madrid, 28010
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28047
GSK Investigational Site
Málaga, 29010
GSK Investigational Site
Manacor, 07500
GSK Investigational Site
Orihuela
GSK Investigational Site
Oviedo, 33006
GSK Investigational Site
Pamplona, 31008
GSK Investigational Site
Sagunto, 46520
GSK Investigational Site
Sant Joan d'Alacant, 3550
GSK Investigational Site
Santa Cruz de Tenerife, 38010
GSK Investigational Site
Seville, 41013
GSK Investigational Site
Seville, 41014
GSK Investigational Site
Seville, 41018
GSK Investigational Site
Seville, 41071
GSK Investigational Site
Soria, 42002
GSK Investigational Site
Valencia, 46009
GSK Investigational Site
Valencia, 46010
GSK Investigational Site
Valencia, 46014
GSK Investigational Site
Valladolid, 47012
GSK Investigational Site
Via-Real (Castellón), 12540
Canada42 sites
GSK Investigational Site
Barrie, Ontario, L4M 7G1
GSK Investigational Site
Burlington, Ontario, L7N 3V2
GSK Investigational Site
Burlington, Ontario, L7S 1V2
GSK Investigational Site
Calgary, Alberta, T2V 4R6
GSK Investigational Site
Chicoutimi, Quebec, G7H 4A3
GSK Investigational Site
Edmonton, Alberta, T5H 4B9
GSK Investigational Site
Fredericton, New Brunswick, E3B 5B8
GSK Investigational Site
Granby, Quebec, J2G 8Z9
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3
GSK Investigational Site
Halifax, Nova Scotia, B3H 1Y6
GSK Investigational Site
Kelowna, British Columbia, V1Y 2H4
GSK Investigational Site
Kingston, Ontario, K7L 2V7
GSK Investigational Site
Kitchener, Ontario, N2N 2B9
GSK Investigational Site
Laval, Quebec, H7G 2E6
GSK Investigational Site
Markham, Ontario, L6B 1A1
GSK Investigational Site
Miramichi, New Brunswick, E1V 1N9
GSK Investigational Site
Montreal, Quebec, H1T 2M4
GSK Investigational Site
Montreal, Quebec, H2L 4M1
GSK Investigational Site
Montreal, Quebec, H2X 3J4
GSK Investigational Site
Montreal, Quebec, H3A 1A1
GSK Investigational Site
Montreal, Quebec, H3S 1Z1
GSK Investigational Site
Montreal, Quebec, H4A 1S9
GSK Investigational Site
Newmarket, Ontario, L3X 1W1
GSK Investigational Site
Niagara Falls, Ontario, L2E 6A6
GSK Investigational Site
North Bay, Ontario, P1B 7K8
GSK Investigational Site
North York, Ontario, M3B 3P1
GSK Investigational Site
Oakville, Ontario, L6H 3P1
GSK Investigational Site
Orillia, Ontario, L3V 7V1
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1R 2J6
GSK Investigational Site
Richmond Hill, Ontario, L4C 1T6
GSK Investigational Site
Saint John, New Brunswick, E2L 3J8
GSK Investigational Site
Surrey, British Columbia, V3V 1N1
GSK Investigational Site
Toronto, Ontario, M1S 4V5
GSK Investigational Site
Toronto, Ontario, M3H 5S4
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Toronto, Ontario, M5G 2M9
GSK Investigational Site
Toronto, Ontario, M6A 3B5
GSK Investigational Site
Trois-Rivières, Quebec, G9A 3V7
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9
GSK Investigational Site
Victoria, British Columbia, V8T 5G1
GSK Investigational Site
Victoria, British Columbia, V8V 3N1
Netherlands21 sites
GSK Investigational Site
's-Hertogenbosch, 5232 JL
GSK Investigational Site
Amsterdam, 1061 AE
GSK Investigational Site
Amsterdam, 1091 AC
GSK Investigational Site
Arnhem, 6815 AD
GSK Investigational Site
Breda, 4819 EV
GSK Investigational Site
Capelle aan den IJssel, 2906 ZC
GSK Investigational Site
Ede, 6716 RP
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Harderwijk, 3844 DG
GSK Investigational Site
Hengelo, 7555 DL
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Nijmegen, 6525 GA
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Roermond, 6040 AX
GSK Investigational Site
Roosendaal, 4708 AE
GSK Investigational Site
Rotterdam, 3015 GD
GSK Investigational Site
Rotterdam, 3078 HT
GSK Investigational Site
Stadskanaal, 9501 HE
GSK Investigational Site
The Hague, 2512 VA
GSK Investigational Site
The Hague, 2545 CH
GSK Investigational Site
Tilburg, 5022 GC
Poland17 sites
GSK Investigational Site
Bydgoszcz, 85-094
GSK Investigational Site
Bydgoszcz, 85-168
GSK Investigational Site
Chęciny, 26-060
GSK Investigational Site
Elblag, 82-300
GSK Investigational Site
Gdansk, 80-462
GSK Investigational Site
Inowrocław, 88-100
GSK Investigational Site
Katowice, 40-954
GSK Investigational Site
Kościerzyna, 83-400
GSK Investigational Site
Krakow, 31-531
GSK Investigational Site
Lublin, 20-718
GSK Investigational Site
Rzeszów, 35-055
GSK Investigational Site
Szczecin, 70-111
GSK Investigational Site
Warsaw, 02-005
GSK Investigational Site
Warsaw, 02-781
GSK Investigational Site
Warsaw, 04-749
GSK Investigational Site
Wejherowo, 84-200
GSK Investigational Site
Wroclaw, 51-124
Italy16 sites
GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Cagliari, Sardinia, 09100
GSK Investigational Site
Caserta, Campania, 81100
GSK Investigational Site
Catania, Sicily, 95124
GSK Investigational Site
Forlì, Emilia-Romagna, 47100
GSK Investigational Site
Isola Della Scala (VR), Veneto, 37063
GSK Investigational Site
Lanciano (CH), Abruzzo, 66034
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Napoli, Veneto, 80131
GSK Investigational Site
Pisa, Tuscany, 56126
GSK Investigational Site
Ragusa (CT), Sicily, 97100
GSK Investigational Site
Rome, Lazio, 00161
GSK Investigational Site
Sassari, Sardinia, 07100
GSK Investigational Site
Voghera (PV), Lombardy, 27058
Sweden15 sites
GSK Investigational Site
Borås, SE-503 32
GSK Investigational Site
Eskilstuna, SE-633 40
GSK Investigational Site
Gävle, SE-801 87
GSK Investigational Site
Gothenburg, SE-412 55
GSK Investigational Site
Gothenburg, SE-417 17
GSK Investigational Site
Karlshamn, SE-374 35
GSK Investigational Site
Kristianstad, SE-291 31
GSK Investigational Site
Kristianstad, SE-291 85
GSK Investigational Site
Malmö, SE-217 44
GSK Investigational Site
Östersund, SE-831 31
GSK Investigational Site
Skärholmen, SE-127 48
GSK Investigational Site
Skövde, SE-541 30
GSK Investigational Site
Stockholm, SE-118 83
GSK Investigational Site
Umeå, SE-901 85
GSK Investigational Site
Vålberg, SE-660 50
Greece14 sites
GSK Investigational Site
Athens, 10552
GSK Investigational Site
Athens, 106 82
GSK Investigational Site
Athens, 10676
GSK Investigational Site
Athens, 115 22
GSK Investigational Site
Athens, 11526
GSK Investigational Site
Athens, 18537
GSK Investigational Site
Heraklion, Crete, 71110
GSK Investigational Site
Ioannina, 45 500
GSK Investigational Site
Larissa, 41110
GSK Investigational Site
Periohi Dragana, Alexandroupolis, 68100
GSK Investigational Site
Rhodes, 85100
GSK Investigational Site
Rio, Patras, 265 00
GSK Investigational Site
Thessaloniki, 54642
GSK Investigational Site
Thessaloniki, 56429
Belgium13 sites
GSK Investigational Site
Aalst, 9300
GSK Investigational Site
Antwerp, 2020
GSK Investigational Site
Brussels, 1000
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Ghent, 9000
GSK Investigational Site
Hasselt, 3500
GSK Investigational Site
Kortrijk, 8500
GSK Investigational Site
Leuven, 3000
GSK Investigational Site
Mons, 7000
GSK Investigational Site
Turnhout, 2300
GSK Investigational Site
Wilrijk, 2610
GSK Investigational Site
Yvoir, 5530
Finland11 sites
GSK Investigational Site
Helsinki, 00029
GSK Investigational Site
Helsinki, 00180
GSK Investigational Site
Kuopio, 70100
GSK Investigational Site
Lahti, 15850
GSK Investigational Site
Lappeenranta, 53100
GSK Investigational Site
Oulu, 90029
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Rovaniemi, 96400
GSK Investigational Site
Seinäjoki, 60220
GSK Investigational Site
Tampere, 33521
GSK Investigational Site
Turku, 20100
Australia10 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Darlinghurst, New South Wales, 2010
GSK Investigational Site
Herston, Queensland, 4029
GSK Investigational Site
Kippa-Ring, Queensland, 4021
GSK Investigational Site
Kogarah, New South Wales, 2217
GSK Investigational Site
Mentone, Victoria, 3194
GSK Investigational Site
Parkville, Victoria, 3050
GSK Investigational Site
Randwick, New South Wales, 2031
GSK Investigational Site
Westmead, New South Wales, 2145
GSK Investigational Site
Woolloongabba, Queensland, 4102
Mexico10 sites
GSK Investigational Site
Durango, Durango, 34000
GSK Investigational Site
Durango, Durango, 34027
GSK Investigational Site
México, 06700
GSK Investigational Site
México, 14000
GSK Investigational Site
Mexico City, 06720
GSK Investigational Site
Mexico City, 14000
GSK Investigational Site
Puebla City, 72500
GSK Investigational Site
Zapopan, Jalisco, 45170
GSK Investigational Site
Zapopan, Jalisco, 45200
GSK Investigational Site
Zapopan, Jalisco, Jalisco, 45100
Argentina9 sites
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, 1120
GSK Investigational Site
Bahía Blanca, Buenos Aires, 8001
GSK Investigational Site
Buenos Aires, C1416DRW
GSK Investigational Site
Capital Federal, Buenos Aires, 1425
GSK Investigational Site
Capital Federal, Buenos Aires, 1437
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH
GSK Investigational Site
Córdoba, Córdoba Province, 5000
GSK Investigational Site
Córdoba, Córdoba Province, 5016
GSK Investigational Site
Rosario, Santa Fe Province, 2000
Russia9 sites
GSK Investigational Site
Moscow, 105 229
GSK Investigational Site
Moscow, 111 123
GSK Investigational Site
Moscow, 117 049
GSK Investigational Site
Moscow, 119 881
GSK Investigational Site
Moscow
GSK Investigational Site
Nizhny Novgorod, 603005
GSK Investigational Site
Saint Petersburg, 197 089
GSK Investigational Site
Saint Petersburg, 198 013
GSK Investigational Site
Saratov, 410012
South Africa9 sites
GSK Investigational Site
Cape Town, 7505
GSK Investigational Site
Cape Town
GSK Investigational Site
Capital Park, 0002
GSK Investigational Site
George, 6529
GSK Investigational Site
Johannesburg, 2193
GSK Investigational Site
Parktown, 2193
GSK Investigational Site
Pretoria, 83
GSK Investigational Site
Rosebank, Gauteng, 2196
GSK Investigational Site
Westville, Durban, 3630
Switzerland9 sites
GSK Investigational Site
Aarau, 5001
GSK Investigational Site
Bern, 3000
GSK Investigational Site
Biel, 2500
GSK Investigational Site
Fribourg, 1700
GSK Investigational Site
Geneva, 1206
GSK Investigational Site
Lausanne, 1003
GSK Investigational Site
Olten, 4600
GSK Investigational Site
Sarnen, 6060
GSK Investigational Site
Zollikon, 8702
Brazil7 sites
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30140-073
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90470-340
GSK Investigational Site
Ribeirão Preto, São Paulo, 14085-000
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, 20 551-030
GSK Investigational Site
Salvador, Estado de Bahia, 40210-341
GSK Investigational Site
São Paulo, São Paulo, 04122-000
Japan6 sites
GSK Investigational Site
Chiba, 289-2511
GSK Investigational Site
Fukuoka, 810-0001
GSK Investigational Site
Hokkaido, 060-8543
GSK Investigational Site
Ibaraki, 305-8576
GSK Investigational Site
Nagasaki, 852-8501
GSK Investigational Site
Ōita, 874-0937
New Zealand6 sites
GSK Investigational Site
Auckland, 1142
GSK Investigational Site
Christchurch, 8014
GSK Investigational Site
Hamilton, 3204
GSK Investigational Site
Nelson, 7010
GSK Investigational Site
Tauranga, 3140
GSK Investigational Site
Whangarei, 0112
Bulgaria5 sites
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Sofia, 1756
GSK Investigational Site
Varna, 9000
Hungary5 sites
GSK Investigational Site
Budapest, 1082
GSK Investigational Site
Budapest, 1204
GSK Investigational Site
Győr, 9002
GSK Investigational Site
Kecskemét, 6000
GSK Investigational Site
Miskolc, 3501
Latvia5 sites
GSK Investigational Site
Daugavpils, LV5403
GSK Investigational Site
Riga, LV 1001
GSK Investigational Site
Riga, LV 1002
GSK Investigational Site
Riga, LV 1006
GSK Investigational Site
Riga, LV1079
Lithuania5 sites
GSK Investigational Site
Kaunas, LT-50009
GSK Investigational Site
Šiauliai, LT-76231
GSK Investigational Site
Vilnius, LT-05263
GSK Investigational Site
Vilnius, LT-08660
GSK Investigational Site
Vilnius, LT-08661
Norway5 sites
GSK Investigational Site
Arendal, N-4838
GSK Investigational Site
Moelv, N-2390
GSK Investigational Site
Oslo, 0257 OSLO
GSK Investigational Site
Porsgrunn, N-3922
GSK Investigational Site
Stavanger, N-4068
Portugal5 sites
GSK Investigational Site
Almada, 2805-267
GSK Investigational Site
Amadora, 2700
GSK Investigational Site
Lisbon
GSK Investigational Site
Porto, 4099-004
GSK Investigational Site
Porto
Tunisia5 sites
GSK Investigational Site
Sfax, 3027
GSK Investigational Site
Sousse, 4054
GSK Investigational Site
Tunis, 1006
GSK Investigational Site
Tunis, 1007
GSK Investigational Site
Tunis, 1008
Slovenia4 sites
GSK Investigational Site
Celje, 3000
GSK Investigational Site
Ljubljana, 1000
GSK Investigational Site
Maribor, 2000
GSK Investigational Site
Slovenj Gradec, 2380
Turkey (Türkiye)4 sites
GSK Investigational Site
Ankara
GSK Investigational Site
Capa/Istanbul
GSK Investigational Site
Istanbul
GSK Investigational Site
Izmir
Ukraine4 sites
GSK Investigational Site
Dnipro, 49005
GSK Investigational Site
Kharkiv, 61037
GSK Investigational Site
Odesa, 65074
GSK Investigational Site
Zaporizhzhya, 69103
Austria3 sites
GSK Investigational Site
Innsbruck, A-6020
GSK Investigational Site
Vienna, A-1090
GSK Investigational Site
Vienna, A-1180
Denmark3 sites
GSK Investigational Site
Herlev, 2730
GSK Investigational Site
Middelfart, 5500
GSK Investigational Site
Nakskov, 4900
Ireland3 sites
GSK Investigational Site
Cork
GSK Investigational Site
Dublin, 7
GSK Investigational Site
Tallaght
Puerto Rico3 sites
GSK Investigational Site
Ponce, Puerto Rico, 00716
GSK Investigational Site
San Juan, Puerto Rico, 00909-1711
GSK Investigational Site
San Juan, Puerto Rico, 00921-3201
Belarus2 sites
GSK Investigational Site
Minsk, 220036
GSK Investigational Site
Minsk, 223052
Chile2 sites
GSK Investigational Site
Santiago, Región Metro de Santiago
GSK Investigational Site
Viña del Mar, Valparaiso
Estonia2 sites
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tallinn
Slovakia2 sites
GSK Investigational Site
Bratislava, 833 05
GSK Investigational Site
Martin, 036 59
Location not given1 site
GSK Investigational Site
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
- Conditions
- Neoplasms, Prostate
- Being tested
- Dutasteride, Placebo
- Keywords
- Prostate cancer prevention, prostate, BPH, enlarged prostate, PSA, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.
PlaceboDrug
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio. Receives: Drug: Placebo |
| dustasteride arm | Experimental | Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center. Receives: Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.
Measured: Years 1-2, Years 3-4, and Overall (Years 1-4)
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.
Measured: Years 1-2, Years 3-4, and Overall (Years 1-4)
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.
Measured: Years 1-2, Years 3-4, and Overall (Years 1-4)
Secondary outcomes (23)
Number of Participants With the Indicated Gleason Score at Diagnosis
Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.
Measured: Baseline to Year 4
Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category ("HGPIN or prostate cancer diagnosis") and again in the last category ("HGPIN, ASAP, or prostate cancer diagnosis").
Measured: Baseline to Year 4
Volume of HGPIN at Biopsy
The amount of prostate biopsy tissue with HGPIN was measured.
Measured: Baseline to Year 4
Percentage of Core Involved at Diagnosis
The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.
Measured: Baseline to Year 4
Number of Cancer-positive Cores
The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.
Measured: Baseline to Year 4
Treatment Alteration Score
The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.
Measured: Baseline to Year 4
Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).
Measured: Baseline to Year 4
Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Measured: Baseline to Year 4 (Month 48)
Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).
Measured: Baseline, Month 24, and Month 48
Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.
Measured: Baseline and Months 12, 24, 36, and 48
Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.
Measured: Years 1-2, Overall (Years 1-4)
Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.
Measured: Years 1-2 and Overall (Years 1-4)
Number of Participants With at Least One Urinary Tract Infection (UTI)
A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.
Measured: Years 1-2, Years 3-4, and Overall (Years 1-4)
Number of Participants With Post-biopsy Macroscopic Hematuria
Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.
Measured: Baseline to Year 4
Number of Participants With Post-biopsy Macroscopic Hematospermia
Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.
Measured: Baseline through Year 4
Overall Survival
Overall survival is assessed as the number of deaths reported throughout the study.
Measured: From time informed consent is signed to 4-month Safety Follow-Up period
Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.
Measured: Baseline and Month 48
Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.
Measured: Baseline and Month 48
Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.
Measured: Baseline and Month 48
Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Measured: Baseline and Month 48
Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.
Measured: Baseline and Month 48
Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.
Measured: Month 48
Mean Change From Baseline in Testosterone at Month 48
Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.
Measured: Baseline and Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2003 (estimated)
- Study startMar 2003
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056407
- Sponsor's protocol ID
- ARI40006
- Acronym
- REDUCE
- Status last verified
- Aug 2016
- First submitted
- 11 Mar 2003
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Kader AK, Sun J, Reck BH, Newcombe PJ, Kim ST, Hsu FC, D'Agostino RB Jr, Tao S, Zhang Z, Turner AR, Platek GT, Spraggs CF, Whittaker JC, Lane BR, Isaacs WB, Meyers DA, Bleecker ER, Torti FM, Trent JM, McConnell JD, Zheng SL, Condreay LD, Rittmaster RS, Xu J. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol. 2012 Dec;62(6):953-61. doi: 10.1016/j.eururo.2012.05.006. Epub 2012 May 12.
PubMed 22652152Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster R, Andriole GL, Groskopf J. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17.
PubMed 20850153Wu C, Moreira DM, Gerber L, Rittmaster RS, Andriole GL, Freedland SJ. Diabetes and prostate cancer risk in the REDUCE trial. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):326-31. doi: 10.1038/pcan.2011.28. Epub 2011 Jun 28.
PubMed 21709690Roehrborn CG, Nickel JC, Andriole GL, Gagnier RP, Black L, Wilson TH, Rittmaster RS. Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011 Sep;78(3):641-6. doi: 10.1016/j.urology.2011.03.063. Epub 2011 Jul 20.
PubMed 21764428Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster RS. Prostate needle biopsy quality in reduction by dutasteride of prostate cancer events study: worldwide comparison of improvement with investigator training and centralized laboratory processing. Urology. 2010 Jun;75(6):1406-10. doi: 10.1016/j.urology.2009.07.1348. Epub 2009 Nov 25.
PubMed 19942263Crawford ED, Andriole GL, Marberger M, Rittmaster RS. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial. Urology. 2010 Mar;75(3):502-9. doi: 10.1016/j.urology.2009.05.099. Epub 2009 Dec 29.
PubMed 20035983G Andriole, D Bostwick, O Brawley, L Gomella, M Marberger, F Montorsi, C Pettaway, T Tammela, C Teloken, D Tindall, M Somerville, I Fowler and R Rittmaster on behalf of the REDUCE Study Group. Risk reduction in men at increased risk: outcomes of the REduction by Dutasteride of prostate Cancer Events (REDUCE) trial. [N Engl J Med]. 2010;362(13):1192-202.
Andriole GL, Bostwick D, Brawley OW, Gomella L, Marberger M, Montorsi F, Pettaway C, Tammela TL, Teloken C, Tindall D, Freedland SJ, Somerville MC, Wilson TH, Fowler I, Castro R, Rittmaster RS; REDUCE Study Group. The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: results from the REDUCE study. J Urol. 2011 Jan;185(1):126-31. doi: 10.1016/j.juro.2010.09.011. Epub 2010 Nov 12.
PubMed 21074214Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127.
PubMed 20357281Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS. Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. J Urol. 2011 Oct;186(4):1313-8. doi: 10.1016/j.juro.2011.05.071. Epub 2011 Aug 17.
PubMed 21849186Jean-Alfred Thomas, II, Leah Gerber, Lionel Banez, Daniel Moreira,Ramiro Castro, Gerald L. Andriole and Stephen J. Freedland. Prostate Cancer Risk in Men with Prostate and Breast Cancer Family History: Results from the REDUCE study. [J Intern Med [Epub Dec 28 2011]]. 2011;
Marberger M, McConnell JD, Fowler I, Andriole GL, Bostwick DG, Somerville MC, Rittmaster RS. Biopsy misidentification identified by DNA profiling in a large multicenter trial. J Clin Oncol. 2011 May 1;29(13):1744-9. doi: 10.1200/JCO.2010.32.1646. Epub 2011 Mar 28.
PubMed 21444877Marberger M, Freedland SJ, Andriole GL, Emberton M, Pettaway C, Montorsi F, Teloken C, Rittmaster RS, Somerville MC, Castro R. Usefulness of prostate-specific antigen (PSA) rise as a marker of prostate cancer in men treated with dutasteride: lessons from the REDUCE study. BJU Int. 2012 Apr;109(8):1162-9. doi: 10.1111/j.1464-410X.2011.10373.x. Epub 2011 Jun 23.
PubMed 21699645Marberger M, Wilson TH, Rittmaster RS. Low serum testosterone levels are poor predictors of sexual dysfunction. BJU Int. 2011 Jul;108(2):256-62. doi: 10.1111/j.1464-410X.2010.09766.x. Epub 2010 Oct 18.
PubMed 20955266Kattan MW, Earnshaw SR, McDade CL, Black LK, Andriole GL. Cost effectiveness of chemoprevention for prostate cancer with dutasteride in a high-risk population based on results from the REDUCE clinical trial. Appl Health Econ Health Policy. 2011 Sep 1;9(5):305-15. doi: 10.2165/11592200-000000000-00000.
PubMed 21875161
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
- ClinicalTrials.gov ID
- NCT00056407
- Acronym / sponsor ID
- REDUCE / ARI40006
- Conditions
- Neoplasms, Prostate
- Keywords
- Prostate cancer prevention, prostate, BPH, enlarged prostate, PSA, prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,231 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 13 Mar 2003 (estimated)
- Results
- Posted 5 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits), and a prostate biopsy will be performed at 2 and 4 years of treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: PlaceboEligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio. |
| dustasteride arm | Experimental | Drug: DutasterideEligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent to participate in study.
- Have had a single negative prostate biopsy within 6 months prior to enrollment in study.
- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a PSA between 3.0 and 10 if over age 60.
- Ability and will to participate in study for 4 years.
Key exclusion criteria (8 listed)
- More than one previous negative prostate biopsy.
- History of prostate cancer.
- Previous prostate surgery.
- Inability to urinate requiring the need of a catheter during the previous 2 years.
- Any condition (other than benign prostatic hypertrophy) which may result in urinary symptoms or changes in urine flow rate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasterideAfter successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years. | Drug | dustasteride arm |
| PlaceboAfter successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years. | Drug | Placebo Arm |
Primary outcome
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.
23 secondary outcomes
Number of Participants With the Indicated Gleason Score at Diagnosis
Time frame: Baseline to Year 4
Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
Time frame: Baseline to Year 4
Volume of HGPIN at Biopsy
Time frame: Baseline to Year 4
Percentage of Core Involved at Diagnosis
Time frame: Baseline to Year 4
Number of Cancer-positive Cores
Time frame: Baseline to Year 4
Treatment Alteration Score
Time frame: Baseline to Year 4
Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
Time frame: Baseline to Year 4
Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
Time frame: Baseline to Year 4 (Month 48)
Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
Time frame: Baseline, Month 24, and Month 48
Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
Time frame: Baseline and Months 12, 24, 36, and 48
Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
Time frame: Years 1-2, Overall (Years 1-4)
Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
Time frame: Years 1-2 and Overall (Years 1-4)
Number of Participants With at Least One Urinary Tract Infection (UTI)
Time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)
Number of Participants With Post-biopsy Macroscopic Hematuria
Time frame: Baseline to Year 4
Number of Participants With Post-biopsy Macroscopic Hematospermia
Time frame: Baseline through Year 4
Overall Survival
Time frame: From time informed consent is signed to 4-month Safety Follow-Up period
Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
Time frame: Baseline and Month 48
Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
Time frame: Baseline and Month 48
Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
Time frame: Baseline and Month 48
Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
Time frame: Baseline and Month 48
Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
Time frame: Baseline and Month 48
Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
Time frame: Month 48
Mean Change From Baseline in Testosterone at Month 48
Time frame: Baseline and Month 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22652152Kader AK, Sun J, Reck BH, Newcombe PJ, Kim ST, Hsu FC, D'Agostino RB Jr, Tao S, Zhang Z, Turner AR, Platek GT, Spraggs CF, Whittaker JC, Lane BR, Isaacs WB, Meyers DA, Bleecker ER, Torti FM, Trent JM, McConnell JD, Zheng SL, Condreay LD, Rittmaster RS, Xu J. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol. 2012 Dec;62(6):953-61. doi: 10.1016/j.eururo.2012.05.006. Epub 2012 May 12.
- Background: PubMed 20850153Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster R, Andriole GL, Groskopf J. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17.
- Background: PubMed 21709690Wu C, Moreira DM, Gerber L, Rittmaster RS, Andriole GL, Freedland SJ. Diabetes and prostate cancer risk in the REDUCE trial. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):326-31. doi: 10.1038/pcan.2011.28. Epub 2011 Jun 28.
- Background: PubMed 21764428Roehrborn CG, Nickel JC, Andriole GL, Gagnier RP, Black L, Wilson TH, Rittmaster RS. Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011 Sep;78(3):641-6. doi: 10.1016/j.urology.2011.03.063. Epub 2011 Jul 20.
- Background: PubMed 19942263Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster RS. Prostate needle biopsy quality in reduction by dutasteride of prostate cancer events study: worldwide comparison of improvement with investigator training and centralized laboratory processing. Urology. 2010 Jun;75(6):1406-10. doi: 10.1016/j.urology.2009.07.1348. Epub 2009 Nov 25.
- Background: PubMed 20035983Crawford ED, Andriole GL, Marberger M, Rittmaster RS. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial. Urology. 2010 Mar;75(3):502-9. doi: 10.1016/j.urology.2009.05.099. Epub 2009 Dec 29.
- BackgroundG Andriole, D Bostwick, O Brawley, L Gomella, M Marberger, F Montorsi, C Pettaway, T Tammela, C Teloken, D Tindall, M Somerville, I Fowler and R Rittmaster on behalf of the REDUCE Study Group. Risk reduction in men at increased risk: outcomes of the REduction by Dutasteride of prostate Cancer Events (REDUCE) trial. [N Engl J Med]. 2010;362(13):1192-202.
- Background: PubMed 21074214Andriole GL, Bostwick D, Brawley OW, Gomella L, Marberger M, Montorsi F, Pettaway C, Tammela TL, Teloken C, Tindall D, Freedland SJ, Somerville MC, Wilson TH, Fowler I, Castro R, Rittmaster RS; REDUCE Study Group. The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: results from the REDUCE study. J Urol. 2011 Jan;185(1):126-31. doi: 10.1016/j.juro.2010.09.011. Epub 2010 Nov 12.
- Background: PubMed 20357281Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127.
- Background: PubMed 21849186Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS. Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. J Urol. 2011 Oct;186(4):1313-8. doi: 10.1016/j.juro.2011.05.071. Epub 2011 Aug 17.
- BackgroundJean-Alfred Thomas, II, Leah Gerber, Lionel Banez, Daniel Moreira,Ramiro Castro, Gerald L. Andriole and Stephen J. Freedland. Prostate Cancer Risk in Men with Prostate and Breast Cancer Family History: Results from the REDUCE study. [J Intern Med [Epub Dec 28 2011]]. 2011;
- Background: PubMed 21444877Marberger M, McConnell JD, Fowler I, Andriole GL, Bostwick DG, Somerville MC, Rittmaster RS. Biopsy misidentification identified by DNA profiling in a large multicenter trial. J Clin Oncol. 2011 May 1;29(13):1744-9. doi: 10.1200/JCO.2010.32.1646. Epub 2011 Mar 28.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
932 sites in 43 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dutasteride in people with Neoplasms, Prostate, run by GlaxoSmithKline at 932 sites in 43 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 932 sites in United States, Germany, France, United Kingdom, Spain and 37 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach) (time frame: Years 1-2, Years 3-4, and Overall (Years 1-4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056407, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.