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Neoplasms, ProstatePhase 4NCT00363311

Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

A Phase 4 study testing Dutasteride in people with Neoplasms, Prostate, run by GlaxoSmithKline at 82 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management). Read more about this study

Who is it for?
Ages 50 to 80 years, men only
Conditions the study is for
Neoplasms, Prostate
What is being tested?
Dutasteride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
302 participants
Where
82 sitesin 2 countries
Study dates
Jul 2006to Jul 2010
Phase
Phase 4
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 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be male ≥48 and ≤82 years of age
  • Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (< 4 cores positive and <50% of any one core positive) and must have been obtained within 8 months of screening]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with <50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.
  • Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
  • Clinical stage T1c-T2a
  • Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory
  • A life expectancy greater than five years.
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  • Able to swallow and retain oral medication
  • Able and willing to participate in the full 3 years of the study
  • Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.

Who cannot join

  • Subject has ever been treated for prostate cancer with any of the following:
  • Radiotherapy (external beam or brachytherapy)
  • Chemotherapy
  • Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol (DES)
  • Oral glucocorticoids
  • Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin)
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  • Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
  • Current and/or previous use of the following medications:
  • Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry are excluded.
  • Any other investigational 5α-reductase inhibitors within the past 12 months.
  • Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
  • Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF).
  • The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.
  • Prostate volume >80 cc
  • Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment
  • Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.
  • Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
  • Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
  • Serum creatinine >1.5 times the upper limit of normal.
  • History of another malignancy within five years that could affect the diagnosis of prostate cancer.
  • History or current evidence of drug or alcohol abuse within the last 12 months.
  • History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
  • Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.

Trial locations and contacts

82 sites in 2 countries.

82 sites in 2 countries

United States58 sites

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Annapolis, Maryland, 21401

  • GSK Investigational Site

    Bala-Cynwyd, Pennsylvania, 19004

  • GSK Investigational Site

    Beverly Hills, California, 90210

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Columbus, Ohio, 43214

  • GSK Investigational Site

    Elmont, New York, 11003

  • GSK Investigational Site

    Englewood, Colorado, 80113

  • GSK Investigational Site

    Fort Wayne, Indiana, 46825

  • GSK Investigational Site

    Garden City, New York, 11530

  • GSK Investigational Site

    Greenbelt, Maryland, 20770

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jacksonville, Florida, 32224

  • GSK Investigational Site

    Laguna Hills, California, 92653

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17604

  • GSK Investigational Site

    Largo, Florida, 33773

  • GSK Investigational Site

    Las Vegas, Nevada, 89148

  • GSK Investigational Site

    Little Rock, Arkansas, 72211

  • GSK Investigational Site

    Marlton, New Jersey, 08053

  • GSK Investigational Site

    Melrose Park, Illinois, 60160

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Minneapolis, Minnesota

  • GSK Investigational Site

    Mission Hills, California, 91345

  • GSK Investigational Site

    Modesto, California, 95350

  • GSK Investigational Site

    Nashville, Tennessee, 37232

  • GSK Investigational Site

    New Britain, Connecticut, 06052

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    Newburgh, Indiana, 47630

  • GSK Investigational Site

    Orchard Park, New York, 14127

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Overland Park, Kansas, 66211

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Richmond, Virginia, 23235

  • GSK Investigational Site

    Roswell, Georgia, 30076

  • GSK Investigational Site

    Saint Cloud, Minnesota, 56303

  • GSK Investigational Site

    Salisbury, North Carolina, 28144

  • 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

    Seattle, Washington, 98101

  • GSK Investigational Site

    Seattle, Washington, 98166

  • GSK Investigational Site

    Shreveport, Louisiana, 71106

  • GSK Investigational Site

    Spokane, Washington, 99202

  • GSK Investigational Site

    Springfield, Oregon, 97477

  • GSK Investigational Site

    St Louis, Missouri, 63136

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Temple, Texas, 76508

  • GSK Investigational Site

    Torrance, California, 90506

  • GSK Investigational Site

    Trumbull, Connecticut, 06611

  • GSK Investigational Site

    Virginia Beach, Virginia, 23455

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20307

  • GSK Investigational Site

    Watertown, Massachusetts, 02472

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Williamsburg, Virginia, 23185

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada24 sites

  • GSK Investigational Site

    Barrie, Ontario, L4M 7G1

  • GSK Investigational Site

    Brampton, Ontario, L6T 3J1

  • GSK Investigational Site

    Brantford, Ontario, N3R 4N3

  • GSK Investigational Site

    Burlington, Ontario, L7N 3V2

  • GSK Investigational Site

    Burlington, Ontario, L7S 1V2

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 4A3

  • GSK Investigational Site

    Fredericton, New Brunswick, E3B 5B8

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H3

  • GSK Investigational Site

    Guelph, Ontario, N1H 5J1

  • GSK Investigational Site

    Kitchener, Ontario, N2N 2B9

  • GSK Investigational Site

    Laval, Quebec, H7G 2E6

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

  • GSK Investigational Site

    North Bay, Ontario, P1B 4Z2

  • GSK Investigational Site

    Oakville, Ontario, L6H 3P1

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R 4S3

  • GSK Investigational Site

    Québec, Quebec, G1R 2J6

  • GSK Investigational Site

    Scarborough Village, Ontario, M1P 2T7

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Toronto, Ontario, M4C 5T2

  • 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

    Victoria, British Columbia, V8T 5G1

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3N1

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).

Being tested
Dutasteride, Matching placebo
Keywords
Dutasteride Prostate Cancer Expectant management REDEEM
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

    Dutasteride 0.5mg

  • Matching placeboDrug

    Matching placebo

Study groups in NCT00363311
Study groupRoleWhat they receive
DutasterideActive comparatorDutasteride 0.5mg
Receives: Drug: Dutasteride
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Matching placebo

What is being measured

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

  1. Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression

    PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.

    Measured: Year 1.5 and Overall (Years 0-3)

Secondary outcomes (29)

  1. Number of Participants With Therapeutic Progression

    Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.

    Measured: Year 1.5 and Overall (Years 0-3)

  2. Number of Participants With Pathologic Progression

    Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.

    Measured: Year 1.5 and Overall (Years 0-3)

  3. Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis

    All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.

    Measured: Baseline to Month 18

  4. Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

    Measured: Years 0-3

  5. Number of Cancer-positive Cores in a 12-core Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  6. Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  7. Mean Percentage of Cancer-positive Cores in a 12-core Biopsy

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  8. Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  9. Cumulative Length of Cancer Tumor Core

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  10. Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3

    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.

    Measured: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)

  11. Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5

    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).

    Measured: Year 1.5

  12. Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3

    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).

    Measured: Years 0-3 (Final Biopsy)

  13. Number of Participants With the Indicated Total Gleason Score

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.

    Measured: Years 0-3 (Final Biopsy)

  14. Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.

    Measured: Baseline

  15. Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage

    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."

    Measured: Months 0-18

  16. Prostate Volume (PV) LOCF

    Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

    Measured: Baseline and Years 1.5 and 3

  17. Change From Baseline in Prostate Volume at Years 1.5 and 3

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.

    Measured: Baseline and Years 1.5 and 3

  18. Percent Change From Baseline in Prostate Volume at Years 1.5 and 3

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.

    Measured: Baseline and Years 1.5 and 3

  19. Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)

    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

    Measured: Baseline and Month 3, 6, 12, 18, and 36

  20. Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF

    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

    Measured: Baseline and Months 3, 6, 12, 18, and 36

  21. Total MAX-PC Anxiety Subscale Score Related to PSA Testing

    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

    Measured: Baseline and Months 3, 6, 12, 18, and 36

  22. Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)

    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

    Measured: Baseline and Months 3, 6, 12, 18, and 36

  23. Total MAX-PC Fear of Recurrence Subscale Score

    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

    Measured: Baseline and Months 3, 6, 12, 18, and 36

  24. Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)

    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

    Measured: Baseline and Months 3, 6, 12, 18, and 36

  25. Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.

    Measured: Baseline and Months 18 and 36

  26. Change From Baseline in Total FACT-P Score (LOCF)

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

    Measured: Baseline and Months 18 and 36

  27. Percent Change From Baseline in Total FACT-P Score (LOCF)

    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

    Measured: Baseline and Months 18 and 36

  28. Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)

    The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.

    Measured: Baseline and Months 18 and 36

  29. Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)

    The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.

    Measured: Baseline and Months 18 and 36

Timeline

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

  1. First posted15 Aug 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2010
  4. Study completionJul 2010

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00363311
Sponsor's protocol ID
AVO105948
Status last verified
Nov 2016
First submitted
11 Aug 2006
Last updated
18 Jan 2017
Data monitoring committee
Yes
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

  • Fleshner NE, Lucia MS, Egerdie B, Aaron L, Eure G, Nandy I, Black L, Rittmaster RS. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. Lancet. 2012 Mar 24;379(9821):1103-11. doi: 10.1016/S0140-6736(11)61619-X. Epub 2012 Jan 24.

    PubMed 22277570

  • Moreira DM, Fleshner NE, Freedland SJ. Baseline Perineural Invasion is Associated with Shorter Time to Progression in Men with Prostate Cancer Undergoing Active Surveillance: Results from the REDEEM Study. J Urol. 2015 Nov;194(5):1258-63. doi: 10.1016/j.juro.2015.04.113. Epub 2015 May 16.

    PubMed 25988518

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dutasteride in people with Neoplasms, Prostate, run by GlaxoSmithKline at 82 sites in 2 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 9 inclusion and 24 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Jun 2011). 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 Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression (time frame: Year 1.5 and Overall (Years 0-3)). 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 NCT00363311, which also lists 2 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 18 Jan 2017.

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