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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Neoplasms, Prostate Prostate Cancer
Interventions:	Drug: Dutasteride Drug: Placebo

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
Dutasteride 0.5 mg	Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.

Participant Flow: Overall Study

	Placebo	Dutasteride 0.5 mg
STARTED	4126	4105
COMPLETED	2915	2912
NOT COMPLETED	1211	1193
Adverse Event	282	364
Withdrawal by Subject	377	361
Lost to Follow-up	123	113
Protocol Violation	104	95
Diagnosed with Prostate Cancer	202	166
Listed as "Other" on Case Report Form	98	60
Missing	25	34

Baseline Characteristics

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Reporting Groups

	Description
Placebo	Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
Dutasteride 0.5 mg	Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.

Baseline Measures

	Placebo	Dutasteride 0.5 mg	Total
Number of Participants [units: participants]	4126	4105	8231
Age [units: years] Mean ± Standard Deviation	62.7 ± 6.08	62.8 ± 6.04	62.8 ± 6.06
Gender [units: participants]
Female	0	0	0
Male	4126	4105	8231
Race/Ethnicity, Customized [units: participants]
White	3747	3744	7491
Black	99	91	190
Asian	67	67	134
American Hispanic	173	160	333
Other	39	43	82
Missing	1	0	1

Outcome Measures

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1. Primary:

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) ]

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2. Primary:

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) ]

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3. Primary:

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) ]

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4. Secondary:

Number of Participants With the Indicated Gleason Score at Diagnosis [ Time Frame: Baseline to Year 4 ]

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5. Secondary:

Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy [ Time Frame: Baseline to Year 4 ]

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6. Secondary:

Volume of HGPIN at Biopsy [ Time Frame: Baseline to Year 4 ]

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7. Secondary:

Percentage of Core Involved at Diagnosis [ Time Frame: Baseline to Year 4 ]

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8. Secondary:

Number of Cancer-positive Cores [ Time Frame: Baseline to Year 4 ]

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9. Secondary:

Treatment Alteration Score [ Time Frame: Baseline to Year 4 ]

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10. Secondary:

Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment [ Time Frame: Baseline to Year 4 ]

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11. Secondary:

Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48 [ Time Frame: Baseline to Year 4 (Month 48) ]

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12. Secondary:

Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48 [ Time Frame: Baseline, Month 24, and Month 48 ]

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13. Secondary:

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 ]

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14. Secondary:

Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms [ Time Frame: Years 1-2, Overall (Years 1-4) ]

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15. Secondary:

Number of Participants With at Least One Event of Acute Urinary Retention (AUR) [ Time Frame: Years 1-2 and Overall (Years 1-4) ]

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16. Secondary:

Number of Participants With at Least One Urinary Tract Infection (UTI) [ Time Frame: Years 1-2, Years 3-4, and Overall (Years 1-4) ]

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17. Secondary:

Number of Participants With Post-biopsy Macroscopic Hematuria [ Time Frame: Baseline to Year 4 ]

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18. Secondary:

Number of Participants With Post-biopsy Macroscopic Hematospermia [ Time Frame: Baseline through Year 4 ]

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19. Secondary:

Overall Survival [ Time Frame: From time informed consent is signed to 4-month Safety Follow-Up period ]

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20. Secondary:

Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48 [ Time Frame: Baseline and Month 48 ]

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21. Secondary:

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 ]

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22. Secondary:

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 ]

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23. Secondary:

Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48 [ Time Frame: Baseline and Month 48 ]

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24. Secondary:

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 ]

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25. Secondary:

Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48 [ Time Frame: Month 48 ]

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26. Secondary:

Mean Change From Baseline in Testosterone at Month 48 [ Time Frame: Baseline and Month 48 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications:

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. Epub 2009 Nov 25.

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

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.

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.

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.

Publications automatically indexed to this study:

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. Epub 2011 Aug 17.

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. Epub 2010 Nov 12.

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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00056407 History of Changes
Other Study ID Numbers:	ARI40006
Study First Received:	March 11, 2003
Results First Received:	February 1, 2010
Last Updated:	November 10, 2011
Health Authority:	Canada: Health Canada; Sweden: Medical Products Agency; United States: Food and Drug Administration