Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00009657

Trial Description

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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

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Trial Acronym

REDUCE

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

[---]*

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Organizational Data

  •   DRKS00009657
  •   2015/11/12
  •   2003/03/11
  •   no
  •   [---]*
  •   [---]*
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Secondary IDs

  •   NCT00056407  (ClinicalTrials.gov)
  •   ARI40006  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Neoplasms, Prostate
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Dutasteride
  •   Drug: Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Prevention
  •   Parallel
  •   III
  •   [---]*
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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.

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Secondary Outcome

- Number of Participants With the Indicated Gleason Score at Diagnosis; time frame: Baseline to Year 4; 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.
- Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy; time frame: Baseline to Year 4; 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").
- Volume of HGPIN at Biopsy; time frame: Baseline to Year 4; The amount of prostate biopsy tissue with HGPIN was measured.
- Percentage of Core Involved at Diagnosis; time frame: Baseline to Year 4; 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.
- Number of Cancer-positive Cores; time frame: Baseline to Year 4; 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.
- Treatment Alteration Score; time frame: Baseline to Year 4; 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.
- Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment; time frame: Baseline to Year 4; 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).
- Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48; time frame: Baseline to Year 4 (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.
- Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48; time frame: Baseline, Month 24, and Month 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).
- 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; 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.
- Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms; time frame: Years 1-2, Overall (Years 1-4); 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.
- Number of Participants With at Least One Event of Acute Urinary Retention (AUR); time frame: Years 1-2 and Overall (Years 1-4); 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.
- Number of Participants With at Least One Urinary Tract Infection (UTI); time frame: Years 1-2, Years 3-4, and Overall (Years 1-4); 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.
- Number of Participants With Post-biopsy Macroscopic Hematuria; time frame: Baseline to Year 4; Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.
- Number of Participants With Post-biopsy Macroscopic Hematospermia; time frame: Baseline through Year 4; Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.
- Overall Survival; time frame: From time informed consent is signed to 4-month Safety Follow-Up period; Overall survival is assessed as the number of deaths reported throughout the study.
- Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48; time frame: Baseline and 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.
- 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; 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.
- 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; 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.
- Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48; time frame: Baseline and 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.
- 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; 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.
- Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48; time frame: 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.
- Mean Change From Baseline in Testosterone at Month 48; time frame: Baseline and Month 48; Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Austria
  •   Belarus
  •   Belgium
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Chile
  •   Croatia
  •   Denmark
  •   Estonia
  •   Finland
  •   France
  •   Germany
  •   Greece
  •   Hungary
  •   Ireland
  •   Italy
  •   Japan
  •   Latvia
  •   Lithuania
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Norway
  •   Poland
  •   Portugal
  •   Puerto Rico
  •   Romania
  •   Russian Federation
  •   Slovakia
  •   Slovenia
  •   South Africa
  •   Spain
  •   Sweden
  •   Switzerland
  •   Tunisia
  •   Turkey
  •   Ukraine
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2003/03/31
  •   8231
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   50   Years
  •   75   Years
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Additional Inclusion Criteria

Inclusion criteria:

- 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.

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Exclusion Criteria

Exclusion criteria:

- 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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GlaxoSmithKline
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    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
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  • start of 1:1-Block address public-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2009/05/01
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Trial Publications, Results and other Documents

  •   Bostwick 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.; 19942263
  •   Stephen J. Freedland, Leah Gerber, Lionel Banez, Daniel Moreira, Gerald L. Andriole, and Roger S. Rittmaster on behalf of the REDUCE Study Group. Statin Use and the Risk of Prostate Cancer and High-grade Prostate Cancer: Results from the REDUCE study. [AUA 2011 Annual Meeting]. 2011;185(4 Suppl):e135.
  •   Andriole 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.; 20357281
  •   Marberger 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.; 20955266
  •   Kattan 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.; 21875161
  •   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.; 21074214
  •   Roehrborn 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.; 21764428
  •   Marberger 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.; 21699645
  •   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.; 22652152
  •   Newcombe PJ, Reck BH, Sun J, Platek GT, Verzilli C, Kader AK, Kim ST, Hsu FC, Zhang Z, Zheng SL, Mooser VE, Condreay LD, Spraggs CF, Whittaker JC, Rittmaster RS, Xu J. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. Genet Epidemiol. 2012 Jan;36(1):71-83. doi: 10.1002/gepi.21600.; 22890972
  •   Nickel 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.; 21849186
  •   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.; 21444877
  •   Thomas JA 2nd, Gerber L, Moreira DM, Hamilton RJ, Bañez LL, Castro-Santamaria R, Andriole GL, Isaacs WB, Xu J, Freedland SJ. Prostate cancer risk in men with prostate and breast cancer family history: results from the REDUCE study (R1). J Intern Med. 2012 Jul;272(1):85-92. doi: 10.1111/j.1365-2796.2011.02504.x. Epub 2012 Jan 16.; 22211699
  •   Muller RL, Gerber L, Moreira DM, Andriole G, Castro R, Freedland SJ. Baseline Serum Testosterone and DHT Levels and the Risk of Prostate Cancer Detection in the Placebo Arm of the REDUCE Trial. [Eur Urol [E-pub 18 May]]. 2012;
  •   Crawford 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. Review.; 20035983
  •   Thomas JA 2nd, Gerber L, Bañez LL, Moreira DM, Rittmaster RS, Andriole GL, Freedland SJ. Prostate cancer risk in men with baseline history of coronary artery disease: results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2012 Apr;21(4):576-81. doi: 10.1158/1055-9965.EPI-11-1017. Epub 2012 Feb 7.; 22315364
  •   Aubin 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.; 20850153
  •   Wu 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.; 21709690
  •   Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster RS, Andriole GL, Groskopf J. Prostate cancer gene 3 score predicts prostate biopsy outcome in men receiving dutasteride for prevention of prostate cancer: results from the REDUCE trial. Urology. 2011 Aug;78(2):380-5. doi: 10.1016/j.urology.2011.03.033.; 21820580
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/07/17


* This entry means the parameter is not applicable or has not been set.