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

Request patient level data

GSK study ID

ARI40006

See study documents

Clinicaltrials.gov ID

NCT00056407

See results summary

EudraCT ID

Not applicable

EU CT Number

Not applicable

Trial status

Completed

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

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