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Neoplasms, ProstateNCT00883909

ARI103094-Follow-Up Study for REDUCE Study Subjects

An observational study of Neoplasms, Prostate, run by GlaxoSmithKline at 267 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of… Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Neoplasms, Prostate
What is being tested?
dutasteride
How many people
2,795 participants
Where
267 sitesin 12 countries
Study dates
9 Apr 2009to 29 Dec 2010
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with or without prostate cancer that participated in the REDUCE trial

Who may be able to join

  • Any subject who has participated in the REDUCE Study and meets one of the following eligibility criteria is eligible for Part A, 2 Year Observational Follow-Up Study:
  • Completed 4 years on Investigational Product through the REDUCE 4 Year study visit (Visit 10) OR
  • Was diagnosed with prostate cancer during the REDUCE study, discontinued Investigational Product (IP) but participated in REDUCE Prostate Cancer Follow-Up visits through the 4 Year study visit (Visit 10P) OR
  • Withdrew from REDUCE study visit participation and IP (for any reasons) but participated in REDUCE Follow-Up phone calls every 6 months through the 4 Year phone call
  • Exclusion Criteria: PART A Subjects meeting the following criterion must not be enrolled in Part A of the study
  • Inability/unwillingness to participate in the Follow-Up Study phone calls.
  • Subjects eligible for enrolment in Part B of the study must meet the following criteria:
  • Any subject who was diagnosed with prostate cancer based on a prostate biopsy during participation in the REDUCE Study, regardless of when their REDUCE study participation ended.

Who cannot join

  • The exclusion criterion only applies to Part A, the 2 year Observational Follow-Up Study. There are no exclusion criteria for Part B, Prostate Biopsy Tissue Study.

Trial locations and contacts

267 sites in 12 countries.

267 sites in 12 countries

United States73 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Anchorage, Alaska, 99508

  • GSK Investigational Site

    Annapolis, Maryland, 21401

  • GSK Investigational Site

    Bala-Cynwyd, Pennsylvania, 19004

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Chaska, Minnesota, 55318

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43214

  • GSK Investigational Site

    Denver, Colorado, 80211

  • GSK Investigational Site

    Englewood, Colorado, 80113

  • GSK Investigational Site

    Fort Wayne, Indiana, 46825

  • GSK Investigational Site

    Galesburg, Illinois, 61401

  • GSK Investigational Site

    Garden City, New York, 11530

  • GSK Investigational Site

    Great Neck, New York, 11021

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Greenwood, Indiana, 46143

  • GSK Investigational Site

    Jeffersonville, Indiana, 47130

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    La Mesa, California, CA 91942

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17604

  • GSK Investigational Site

    Little Rock, Arkansas, 72211

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Longwood, Florida, 32750

  • GSK Investigational Site

    Los Angeles, California, 90048

  • GSK Investigational Site

    Los Angeles, California, 90073

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209

  • GSK Investigational Site

    Myrtle Beach, South Carolina, 29572

  • GSK Investigational Site

    Nashville, Tennessee, 37232 5770

  • GSK Investigational Site

    New Britain, Connecticut, 06052

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Omaha, Nebraska, 68114

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Overland Park, Kansas, 66211

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19144

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19152

  • GSK Investigational Site

    Phoenix, Arizona, 85032

  • GSK Investigational Site

    Pinecrest, Florida, 33156

  • GSK Investigational Site

    Pinellas Park, Florida, 33782

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Ponca City, Oklahoma, 74601

  • GSK Investigational Site

    Portland, Oregon, 97205

  • 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

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Royal Oak, Michigan, 48073

  • GSK Investigational Site

    Saint Joseph, Michigan, 49085

  • GSK Investigational Site

    San Bernardino, California, 92404

  • GSK Investigational Site

    San Diego, California, 92120

  • GSK Investigational Site

    Sartell, Minnesota, 56377

  • GSK Investigational Site

    Seattle, Washington, 98166

  • GSK Investigational Site

    Sheffield, Ohio, 44035

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    State College, Pennsylvania, 16801

  • GSK Investigational Site

    Staten Island, New York, 10304

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tarzana, California, 91356

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Virginia Beach, Virginia, 23454

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20307

  • GSK Investigational Site

    Watertown, Massachusetts, 02472

  • GSK Investigational Site

    West Orange, New Jersey, 07052

  • GSK Investigational Site

    Wichita, Kansas, 67208

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany60 sites

  • GSK Investigational Site

    Aichach, Bavaria, 86551

  • GSK Investigational Site

    Backnang, Baden-Wurttemberg, 71522

  • GSK Investigational Site

    Bad Bergzaben, Rhineland-Palatinate, 76887

  • GSK Investigational Site

    Bad Schlema, Saxony, 08301

  • GSK Investigational Site

    Bautzen, Saxony, 02625

  • GSK Investigational Site

    Berlin, 10249

  • GSK Investigational Site

    Berlin, 10369

  • GSK Investigational Site

    Berlin, 12627

  • GSK Investigational Site

    Berlin, 13187

  • GSK Investigational Site

    Berlin, 14057

  • GSK Investigational Site

    Bruchsal, Baden-Wurttemberg, 76646

  • GSK Investigational Site

    Buchholz, Lower Saxony, 21244

  • GSK Investigational Site

    Chemnitz, Saxony, 09119

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50969

  • GSK Investigational Site

    Döbeln, Saxony, 04720

  • GSK Investigational Site

    Eisleben Lutherstadt, Saxony-Anhalt, 06295

  • GSK Investigational Site

    Erkrath, North Rhine-Westphalia, 40699

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60326

  • GSK Investigational Site

    Ganderkesee, Lower Saxony, 27777

  • GSK Investigational Site

    Gardelegen, Saxony-Anhalt, 39638

  • GSK Investigational Site

    Gelsenkirchen, North Rhine-Westphalia, 45883

  • GSK Investigational Site

    Gotha, Thuringia, 99867

  • GSK Investigational Site

    Grimma, Saxony, 04668

  • GSK Investigational Site

    Hagenow, Brandenburg, 19230

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06132

  • GSK Investigational Site

    Hamburg, 22459

  • GSK Investigational Site

    Hennigsdorf, Brandenburg, 16761

  • GSK Investigational Site

    Herzogenaurach, Bavaria, 91074

  • GSK Investigational Site

    Hettstedt, Saxony-Anhalt, 06333

  • GSK Investigational Site

    Hochheim am Main, Hesse, 65239

  • GSK Investigational Site

    Holzminden, Lower Saxony, 37603

  • GSK Investigational Site

    Ilmenau, Thuringia, 98693

  • GSK Investigational Site

    Kempen, North Rhine-Westphalia, 47906

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24143

  • 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

    Lübeck, Schleswig-Holstein, 23552

  • GSK Investigational Site

    Marburg, Hesse, 35039

  • GSK Investigational Site

    Munich, Bavaria, 81927

  • GSK Investigational Site

    Neckargemünd, Baden-Wurttemberg, 69151

  • GSK Investigational Site

    Neustadt, Saxony, 01844

  • GSK Investigational Site

    Nuremberg, Bavaria, 90441

  • GSK Investigational Site

    Oranienburg, Brandenburg, 16515

  • GSK Investigational Site

    Planegg, Bavaria, 82152

  • GSK Investigational Site

    Plauen, Saxony, 08523

  • GSK Investigational Site

    Plön, Schleswig-Holstein, 24306

  • GSK Investigational Site

    Radebeul, Saxony, 01445

  • GSK Investigational Site

    Schwarzenberg, Saxony, 08340

  • GSK Investigational Site

    Seligenstadt, Hesse, 63500

  • GSK Investigational Site

    Senftenberg, Brandenburg, 01968

  • GSK Investigational Site

    Strausberg, Brandenburg, 15344

  • GSK Investigational Site

    Tirschenreuth, Bavaria, 95643

  • GSK Investigational Site

    Wilkau-Haßlau, Saxony, 08112

  • GSK Investigational Site

    Wismar, Mecklenburg-Vorpommern, 23970

  • GSK Investigational Site

    Zwickau, Saxony, 08060

Other trials in Germany

Spain29 sites

  • GSK Investigational Site

    Alava, 01004

  • GSK Investigational Site

    Alcala de Henares (Madrid)

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 8907

  • GSK Investigational Site

    Bilbao, 48013

  • GSK Investigational Site

    Ciudad Real, 13600

  • GSK Investigational Site

    Don Benito (Badajoz), 06400

  • GSK Investigational Site

    Galdakano, 48960

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Ibiza Town, 07800

  • GSK Investigational Site

    La Laguna-Tenerife, 38320

  • GSK Investigational Site

    Logroño, 26006

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Madrid, 28047

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Manacor (Palma de Mallorca), 07500

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    Sagunto, 46520

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Sant Joan d'Alacant, 3550

  • GSK Investigational Site

    Seville, 41003

  • GSK Investigational Site

    Soria, 42002

  • GSK Investigational Site

    Valencia, 46009

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46014

  • GSK Investigational Site

    Valladolid, 47010

Other trials in Spain

France23 sites

  • GSK Investigational Site

    Auch, 32000

  • GSK Investigational Site

    Bourgoin, 38300

  • GSK Investigational Site

    Cannes, 06400

  • GSK Investigational Site

    Carpentras, 84200

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Dijon, 21000

  • GSK Investigational Site

    Le Havre, 76600

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Longjumeau, 91161

  • GSK Investigational Site

    Lyon, 69437

  • GSK Investigational Site

    Mantes-la-Jolie, 78200

  • GSK Investigational Site

    Montauban, 82000

  • GSK Investigational Site

    Montpellier, 34000

  • GSK Investigational Site

    Orléans, 45100

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Paris, 75877

  • GSK Investigational Site

    Ploemeur, 56270

  • GSK Investigational Site

    Saint-Etienne, 42000

  • GSK Investigational Site

    Saint-Martin-d'Hères, 38400

  • GSK Investigational Site

    Suresnes, 92151

  • GSK Investigational Site

    Toulouse, 31403

  • GSK Investigational Site

    Tours, 37044

  • GSK Investigational Site

    Troyes, 10000

Other trials in France

Canada22 sites

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Calgary, Alberta, T2V 1P9

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 4A3

  • GSK Investigational Site

    Granby, Quebec, J2G 8Z9

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H3

  • GSK Investigational Site

    Kelowna, British Columbia, V1Y 2H4

  • GSK Investigational Site

    Kingston, Ontario, K7L 2V7

  • GSK Investigational Site

    Laval, Quebec, H7G 2E6

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H2X 3J4

  • GSK Investigational Site

    Newmarket, Ontario, L3X 1W1

  • GSK Investigational Site

    Oakville, Ontario, L6H 3P1

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Toronto, Ontario, M1S 4V5

  • GSK Investigational Site

    Toronto, Ontario, M3B 3S6

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9

  • GSK Investigational Site

    Toronto, Ontario, M6A 3B5

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3N1

  • GSK Investigational Site

    Waterloo, Ontario, N2J 1C4

Other trials in Canada

United Kingdom15 sites

  • GSK Investigational Site

    Bristol, BS2 8HW

  • GSK Investigational Site

    Buckshaw Village, Chorley, Lancashire, PR7 7NA

  • GSK Investigational Site

    Cardiff, CF14 5GJ

  • GSK Investigational Site

    Chichester, Sussex West, PO19 4SE

  • GSK Investigational Site

    Clydebank, Glasgow, G81 2DR

  • GSK Investigational Site

    Edgbaston, Birmingham, B15 2SQ

  • GSK Investigational Site

    Exeter, Devon, EX2 5DW

  • GSK Investigational Site

    High Heaton, Newcastle Upon Tyne, NE7 7PN

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    Liverpool, Merseyside, L22 0LG

  • GSK Investigational Site

    Nottingham, Nottinghamshire, NG5 1PB

  • GSK Investigational Site

    Plymouth, Devon, PL6 8DH

  • GSK Investigational Site

    Reading, Berkshire, RG2 0TG

  • GSK Investigational Site

    Torquay, TQ2 7AA

  • GSK Investigational Site

    Waterloo, Liverpool, L22 0LG

Other trials in United Kingdom

Netherlands14 sites

  • GSK Investigational Site

    Amsterdam, 1091 AC

  • GSK Investigational Site

    Arnhem, 6815 AD

  • 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

    Nieuwegein, 3435 CM

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    Nijmegen, 6532 SZ

  • GSK Investigational Site

    Roermond, 6040 AX

  • GSK Investigational Site

    Rotterdam, 3078 HT

  • GSK Investigational Site

    The Hague, 2512 VA

  • GSK Investigational Site

    The Hague, 2545 CH

  • GSK Investigational Site

    Tilburg, 5022 GC

Other trials in Netherlands

Sweden13 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-413 46

  • GSK Investigational Site

    Karlshamn, SE-374 35

  • GSK Investigational Site

    Kristianstad, SE-291 31

  • GSK Investigational Site

    Malmö, SE-217 44

  • GSK Investigational Site

    Östersund, SE-831 40

  • GSK Investigational Site

    Stockholm, SE-117 94

  • GSK Investigational Site

    Stockholm, SE-118 83

  • GSK Investigational Site

    Umeå, SE-901 85

  • GSK Investigational Site

    Vålberg, SE-660 50

Other trials in Sweden

Greece7 sites

  • GSK Investigational Site

    Athens, 10552

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Heraklion, Crete, 71110

  • GSK Investigational Site

    Larissa, 41110

  • GSK Investigational Site

    Periohi Dragana, Alexandroupolis, 68100

  • GSK Investigational Site

    Rhodes, 85100

  • GSK Investigational Site

    Thessaloniki, 56429

Other trials in Greece

Finland6 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Lappeenranta, 53100

  • GSK Investigational Site

    Oulu, 90029

  • GSK Investigational Site

    Oulu, 90100

  • GSK Investigational Site

    Seinäjoki, 60220

  • GSK Investigational Site

    Tampere, 33521

Other trials in Finland

Argentina4 sites

  • GSK Investigational Site

    Av Córdoba 2424, Buenos Aires, 1120

  • GSK Investigational Site

    Capital Federal, Buenos Aires, 1437

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1121AAF

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1405BCH

Other trials in Argentina

Chile1 site

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

Other trials in Chile

About this study

ARI103094 is a follow-up study in adult male subjects who have received investigational product (either dutasteride or placebo) in the REDUCE Study (REduction by DUasteride of prostate Cancer Events), ARI40006, A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer. There are 2 parts to this REDUCE Follow-Up Study, Part A and Part B:

  • REDUCE Follow-Up Study, Part A, is a 2 year observational study which will follow eligible subjects for 2 years after completion of the 4 Contact in the REDUCE study. Eligible subjects for Part A, the 2 Year Observational Study fall into 3 groups as follows: (1) REDUCE subjects who completed treatment with investigational product (dutasteride or placebo) through the REDUCE 4 Year study visit [Visit 10], (2) REDUCE subjects who developed prostate cancer, were withdrawn from investigational product and participated in Prostate Cancer follow-up until the REDUCE 4 Year study visit [Visit 10P] or (3) REDUCE subjects who were withdrawn from investigational product and participated in observational phone follow up until the REDUCE 4 Year phone call after withdrawing from IP (expected Visit 10). The objective of this observational study for eligible REDUCE subjects is to collect and summarize data on prostate cancer (the incidence of newly diagnosed prostate cancers and changes in prostate cancer diagnosed during the REDUCE study) and serious adverse events (SAEs) for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled study, REDUCE.
  • REDUCE Follow-Up Study, Part B, is for collection of cancer positive prostate biopsy tissue blocks/slides from subjects who were diagnosed with prostate cancer in the REDUCE study.
Being tested
dutasteride
Keywords
Prostate Cancer, Benign Prostatic Hyperplasia
Medical subject headings
Prostatic Neoplasms, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dutasterideDrug

    A follow-up study in adult male subjects who have received investigational product

Study groups in NCT00883909
Study groupRoleWhat they receive
observationalA follow-up study in adult male subjects who have received investigational
Receives: Drug: dutasteride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.

    Measured: 2 years

Secondary outcomes (1)

  1. To collect and summarize data on Adverse Events for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2009 (estimated)
  2. Study start9 Apr 2009
  3. Primary completion1 Dec 2010
  4. Study completion29 Dec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,795 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00883909
Sponsor's protocol ID
103094
Status last verified
Jul 2017
First submitted
16 Apr 2009
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
No
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

  • Grubb RL, Andriole GL, Somerville MC, Mahoney C, Manyak MJ, Castro R. The REDUCE Follow-Up Study: low rate of new prostate cancer diagnoses observed during a 2-year, observational, followup study of men who participated in the REDUCE trial. J Urol. 2013 Mar;189(3):871-7. doi: 10.1016/j.juro.2012.09.099. Epub 2012 Sep 25.

    PubMed 23021996

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms, Prostate, run by GlaxoSmithKline at 267 sites in 12 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 8 inclusion and 1 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 267 sites in United States, Germany, Spain, France, Canada and 7 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To collect and summarize data for 2 years beyond the prospectively planned 4 year double blind, placebo-controlled REDUCE study. (time frame: 2 years). 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 NCT00883909, which also lists 1 linked publication.

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 11 Jul 2017.

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