Last updated: 11/04/2018 04:53:27
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased RiskREDUCE
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with biopsy-detectable prostate cancer at Years 2 and 4 (crude rate approach)
Timeframe: 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)
Timeframe: 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)
Timeframe: Years 1-2, Years 3-4, and Overall (Years 1-4)
Secondary outcomes:
Number of participants with the indicated Gleason score at diagnosis
Timeframe: Baseline to Year 4
Number of participants with HGPIN, ASAP, and prostate cancer at biopsy
Timeframe: Baseline to Year 4
Volume of HGPIN at biopsy
Timeframe: Baseline to Year 4
Percentage of core involved at diagnosis
Timeframe: Baseline to Year 4
Number of cancer-positive cores
Timeframe: Baseline to Year 4
Treatment alteration score
Timeframe: Baseline to Year 4
Number of participants undergoing intervention (surgical and non-surgical) for prostate cancer treatment
Timeframe: Baseline to Year 4
Adjusted mean change from baseline in the International Prostate Symptom Score (IPSS) at Month 48
Timeframe: Baseline to Year 4 (Month 48)
Adjusted mean percentage change from baseline in prostate volume at Months 24 and 48
Timeframe: Baseline, Month 24, and Month 48
Adjusted mean change from baseline in maximum urinary flow (Qmax) at Months 12, 24, 36, and 48
Timeframe: Baseline and Months 12, 24, 36, and 48
Number of participants starting alpha blockers to control benign prostatic hyperplasia (BPH) symptoms
Timeframe: Years 1-2, Overall (Years 1-4)
Number of participants with at least one event of acute urinary retention (AUR)
Timeframe: Years 1-2 and Overall (Years 1-4)
Number of participants with at least one urinary tract infection (UTI)
Timeframe: Years 1-2, Years 3-4, and Overall (Years 1-4)
Number of participants with post-biopsy macroscopic hematuria
Timeframe: Baseline to Year 4
Number of participants with post-biopsy macroscopic hematospermia
Timeframe: Baseline through Year 4
Overall Survival
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and Month 48
Adjusted mean change from baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
Timeframe: Baseline and Month 48
Adjusted mean change from baseline in Quality of Life Question 8 (QOL Q8) at Month 48
Timeframe: Baseline and Month 48
Adjusted mean change from baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
Timeframe: Baseline and Month 48
Number of participants with the indicated serum dihydrotestosterone (DHT) concentration at Month 48
Timeframe: Month 48
Mean change from baseline in testosterone at Month 48
Timeframe: Baseline and Month 48
Interventions:
Enrollment:
8231
Primary completion date:
2009-11-05
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A. K. Kader, J. Sun, B. H. Reck, P. J. Newcombe, Seong-Tae Kim, Tao Jin, Zheng Zhang, Sha Tao, Greg T. Platek, Colin F. Spraggs, John C. Whittaker, Vincent E. Mooser, John D. McConnell, S. Lilly Zheng, Lynn D. Condreay, Roger S. Rittmaster, Jianfeng Xu.. 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 [E-Pub 11 May]]. 2012;
Aubin SMJ, 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;184(4):1947-52.
Chenwei Wu; Daniel M. Moreira; Leah Gerber; Roger S. Rittmaster; Gerald L. Andriole; Stephen J. Freedland. DIABETES AND PROSTATE CANCER RISK IN THE REDUCE TRIAL. [Prostate Cancer Prostatic Dis]. 2011;14(4):326-31.
Claus G. Roehrborn, J. Curtis Nickel, Gerald L. Andriole, R. Paul Gagnier, Libby Black, Tim Wilson, Roger S. Rittmaster . Dutasteride improves the outcomes of benign prostatic hyperplasia: a secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. [Urology]. 2011;73(3):641-6.
David G. Bostwick, Junqi Qian, Krystyna Drewnowska, Stephen Varvel, Kathleen C. Bostwick, Michael Marberger, Roger S. Rittmaster . Prostate Needle Biopsy Quality in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) Study: Worldwide Comparison of the Improvement with Investigator Training and Centralized Laboratory Processing. Urology. 2009;Nov 24:
David G. Bostwick, Junqi Qian, Krystyna Drewnowska, Stephen Varvel, Kathleen C. Bostwick, Michael Marberger, and Roger S. Rittmaster. REDUCE 4yr: Pathology, RP (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;75(6):1406-11.
E. David Crawford, Gerald Andriole, Michael Marberger, Roger Rittmaster. Reduction in the risk of prostate cancer: future directions after PCPT. Urology. 2009;Dec 24:
G 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.
Gerald L. Andriole on behalf of the 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. [Journal of Urology]. 2011;185(1):126-131.
Gerald L. Andriole, David G. Bostwick, Otis W. Brawley, Leonard G. Gomella, Michael Marberger, Francesco Montorsi, Curtis A. Pettaway, Teuvo L. Tammela, Claudio Teloken, Donald J. Tindall, Matthew C. Somerville, Timothy H. Wilson, Ivy L. Fowler, Roger S. Rittmaster. Effect of Dutasteride on the Risk of Prostate Cancer. N Engl J Med. 2010;362:1192-202
J. Curtis Nickel, Claus Roehrborn, Francesco Montorsi,Timothy Wilson, Roger S. Rittmaster. DUTASTERIDE REDUCES PROSTATITIS SYMPTOMS COMPARED TO PLACEBO IN MEN ENROLLED IN THE REDUCE (REDUCTION OF DUTASTERIDE IN CANCER EVENTS) STUDY. [J Urol]. 2011;186(4):1313-8.
Jean-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;
Michael Marberger, John D. McConnell, Ivy Fowler, Gerald L. Andriole, David G. Bostwick, Matthew C. Somerville, Roger S. Rittmaster. Biopsy Misidentification Identified by DNA Profiling in a Large Multicenter Trial. [J Clin Oncol]. 2011;29(13):1744-9.
Michael Marberger, Stephen J. Freedland, Gerald L. Andriole, Mark Emberton, Curtis A. Pettaway, Francesco Montorsi, Claudio Teloken, Roger S. Rittmaster, Matthew Somerville and Ramiro Castro. 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]. 2011;109(8):1162-1169.
Michael Marberger, Tim Wilson, Roger Rittmaster. Low serum testosterone levels are poor predictors of sexual dysfunction . [BJU Int]. 2011;108(2):256-62.
Michael W. Kattan, Stephanie R. Earnshaw, Cheryl L. McDade, Libby K. Black, Gerald L. Andriole. Cost-Effectiveness of Chemoprevention with Dutasteride Based on Results from the REDUCE Clinical Trial . [Appl Health Econ Health Policy]. 2011;9(5):305-15.
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;
Newcombe PJ, Reck BH, Sun J, Platek GT, Verzill Ci, Karim Kader A, Kim S-T, Jin T, Zhang Z, Zheng SL, Condreay LD et al.. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. [Genetics Epidemiology]. 2012;36(1):71-83.
Sheila M. J. Aubin, Jennifer Reid, Mark J. Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, Roger S. Rittmaster, Gerald L. Andriole, Jack Groskopf. 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;78(2):380-5.
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.
Thomas II J-A, Gerber L, Moreira DM, Banez L, Andriole G, Rittmaster RS, Freedland SJ. Prostate Cancer Risk in Men with Baseline History of Coronary Artery Disease: Results from the REDUCE study. [Cancer Epidemiol Biomarkers Prev]. 2012;21(4):576-81.
Andriole GA, Bostwick D, Gomella L, Marberger M, Montorsi F, Tammela T, Tindall D, Rittmaster RS, Gould I, Garges H, Wilson TH, Castro R.Modeling and analysis of Gleason score 8–10 prostate cancers in the REDUCE study.Urology.2014;84(2):393–399
Aubin SMJ, 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;184(4):1947-52.
Chenwei Wu; Daniel M. Moreira; Leah Gerber; Roger S. Rittmaster; Gerald L. Andriole; Stephen J. Freedland. DIABETES AND PROSTATE CANCER RISK IN THE REDUCE TRIAL. Prostate Cancer Prostatic Dis. 2011;14(4):326-31.
Claus G. Roehrborn, J. Curtis Nickel, Gerald L. Andriole, R. Paul Gagnier, Libby Black, Tim Wilson, Roger S. Rittmaster . Dutasteride improves the outcomes of benign prostatic hyperplasia: a secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011;73(3):641-6.
David G. Bostwick, Junqi Qian, Krystyna Drewnowska, Stephen Varvel, Kathleen C. Bostwick, Michael Marberger, and Roger S. Rittmaster. REDUCE 4yr: Pathology, RP (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;75(6):1406-11.
G 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. Effect of Dutasteride on the Risk of Prostate Cancer. N Engl J Med. 2010;362(13):1192-1202.
Gerald L. Andriole on behalf of the 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. Journal of Urology. 2011;185(1):126-131.
J. Curtis Nickel, Claus Roehrborn, Francesco Montorsi,Timothy Wilson, Roger S. Rittmaster. DUTASTERIDE REDUCES PROSTATITIS SYMPTOMS COMPARED TO PLACEBO IN MEN ENROLLED IN THE REDUCE (REDUCTION OF DUTASTERIDE IN CANCER EVENTS) STUDY. J Urol. 2011;186(4):1313-1318.
Lucia S, Somerville M, Fowler I, Rittmaster R, Bostwick D. Comparison of classic and International Society of Urological Pathology 2005 Modified Gleason grading using needle biopsies from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Arch Pathol Lab Med. 2013;137(12):1740-6.
Michael Marberger, John D. McConnell, Ivy Fowler, Gerald L. Andriole, David G. Bostwick, Matthew C. Somerville, Roger S. Rittmaster. Biopsy Misidentification Identified by DNA Profiling in a Large Multicenter Trial. J Clin Oncol. 2011;29(13):1744-9.
Michael Marberger, Stephen J. Freedland, Gerald L. Andriole, Mark Emberton, Curtis A. Pettaway, Francesco Montorsi, Claudio Teloken, Roger S. Rittmaster, Matthew Somerville and Ramiro Castro. 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. 2011;109(8):1162-1169.
Michael Marberger, Tim Wilson, Roger Rittmaster. Low serum testosterone levels are poor predictors of sexual dysfunction . BJU Int. 2011;108(2):256-62.
Michael W. Kattan, Stephanie R. Earnshaw, Cheryl L. McDade, Libby K. Black, Gerald L. Andriole. Cost-Effectiveness of Chemoprevention with Dutasteride Based on Results from the REDUCE Clinical Trial . Appl Health Econ Health Policy. 2011;9(5):305-15.
Newcombe PJ, Reck BH, Sun J, Platek GT, Verzill Ci, Karim Kader A, Kim S-T, Jin T, Zhang Z, Zheng SL, Condreay LD et al.. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. Genetics Epidemiology. 2012;36(1):71-83.
Sheila M. J. Aubin, Jennifer Reid, Mark J. Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, Roger S. Rittmaster, Gerald L. Andriole, Jack Groskopf. 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;78(2):380-5.
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.
Thomas II J-A, Gerber L, Moreira DM, Banez L, Andriole G, Rittmaster RS, Freedland SJ. Prostate Cancer Risk in Men with Baseline History of Coronary Artery Disease: Results from the REDUCE study. Cancer Epidemiol Biomarkers Prev. 2012;21(4):576-81.
Medical condition
Neoplasms, Prostate
Product
dutasteride
Collaborators
Not applicable
Study date(s)
March 2003 to May 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Male
Age
50 - 75 years
Accepts healthy volunteers
No
- Inclusion criteria:
- Informed consent to participate in study.
Inclusion and exclusion criteria
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. 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.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Mechanicsville, Virginia, United States, 23116
Status
Study Complete
Location
GSK Investigational Site
Ostfildern, Baden-Wuerttemberg, Germany, 73760
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14642
Status
Terminated/Withdrawn
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Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-11-05
Actual study completion date
2009-11-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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