"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk

Summary

This 4-year study will compare how safe and effective an oral investigational medicine is (compared to placebo) in preventing the development of prostate cancer in men that are defined by the study entrance criteria as being at an increased risk for prostate cancer. 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.

Timeline

Start

2003-03

Primary completion

2009-01

Completion

2009-04

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Dutasteride 0.5 mg; p <0.0001; Relative Risk Reduction 23.3 (95% CI 15.6 to 30.3) NCT00056407 ↗

registry analysis (superiority or other test); Placebo vs Dutasteride 0.5 mg; p <0.0001; Relative Risk Reduction 23.1 (95% CI 15.5 to 30.0) NCT00056407 ↗

registry analysis (superiority or other test); Placebo vs Dutasteride 0.5 mg; p <0.0001; Relative Risk Reduction 22.8 (95% CI 15.2 to 29.8) NCT00056407 ↗

release “REDUCE achieved its primary endpoint and demonstrated that dutasteride significantly reduced the risk of all biopsy-detectable prostate cancer by 23%” gsk.com ↗

Publications

• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background 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;
• Background 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.
• Background 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.
• Background 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.
• Background 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.
• Background Muller RL, Gerber L, Moreira DM, Andriole G, Castro-Santamaria R, Freedland SJ. Serum testosterone and dihydrotestosterone and prostate cancer risk in the placebo arm of the Reduction by Dutasteride of Prostate Cancer Events trial. Eur Urol. 2012 Nov;62(5):757-64. doi: 10.1016/j.eururo.2012.05.025. Epub 2012 May 18.
• Background 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.
• Background 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.
• Background 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.
• Background Thomas JA 2nd, Gerber L, Banez 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.
• Vidal AC, Oyekunle T, Feng T, Freedland AR, Moreira D, Castro-Santamaria R, Andriole GL, Freedland SJ, Allott EH. Asian Race and Risk of Prostate Cancer: Results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2020 Nov;29(11):2165-2170. doi: 10.1158/1055-9965.EPI-20-0646. Epub 2020 Aug 20.
• Bliwise DL, Howard LE, Moreira DM, Andriole GL, Hopp ML, Freedland SJ. Nocturia and associated mortality: observational data from the REDUCE trial. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):77-83. doi: 10.1038/s41391-018-0090-5. Epub 2018 Sep 13.
• Moreira DM, Andriole GL, Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ. Dutasteride is associated with reduced risk of transrectal prostate biopsy-associated urinary tract infection and related hospitalizations. World J Urol. 2017 Oct;35(10):1525-1530. doi: 10.1007/s00345-017-2036-2. Epub 2017 Apr 10.
• Nickel JC, Roehrborn CG, Castro-Santamaria R, Freedland SJ, Moreira DM. Chronic Prostate Inflammation is Associated with Severity and Progression of Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Risk of Acute Urinary Retention. J Urol. 2016 Nov;196(5):1493-1498. doi: 10.1016/j.juro.2016.06.090. Epub 2016 Jul 1.
• Moreira DM, Nickel JC, Andriole GL, Castro-Santamaria R, Freedland SJ. Chronic baseline prostate inflammation is associated with lower tumor volume in men with prostate cancer on repeat biopsy: Results from the REDUCE study. Prostate. 2015 Sep;75(13):1492-8. doi: 10.1002/pros.23041. Epub 2015 Jul 17.
• Moreira DM, Bostwick DG, Andriole GL, Peterson BL, Cohen HJ, Castro-Santamaria R, Freedland SJ. Baseline Prostate Atrophy is Associated with Reduced Risk of Prostate Cancer in Men Undergoing Repeat Prostate Biopsy. J Urol. 2015 Nov;194(5):1241-6. doi: 10.1016/j.juro.2015.05.103. Epub 2015 Jul 10.
• Toren P, Margel D, Kulkarni G, Finelli A, Zlotta A, Fleshner N. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ. 2013 Apr 15;346:f2109. doi: 10.1136/bmj.f2109.
• Muller RL, Gerber L, Moreira DM, Andriole G Jr, Hamilton RJ, Fleshner N, Parsons JK, Freedland SJ. Obesity is associated with increased prostate growth and attenuated prostate volume reduction by dutasteride. Eur Urol. 2013 Jun;63(6):1115-21. doi: 10.1016/j.eururo.2013.02.038. Epub 2013 Mar 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dutasteride	Small molecule	0.5 mg	Oral

Indications