Economic Analyses of the REDUCE Trial

Completed

• Conditions: Benign Prostatic Hyperplasia; Neoplasms, Prostate; Cancer
• Interventions: Drug: Dutasteride; Drug: Placebo

• Registration Number: NCT01337258
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.

The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-04
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted QC: 2011-04-14
• Study First Posted: 2011-04-18
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-25
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Men aged 50 to 75 years
• serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged >60 years)
• single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)

Exclusion Criteria

• Principal exclusion criteria were more than one prior prostate biopsy
• high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
• a prostate volume >80 ml, previous prostate surgery
• International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Men at increased risk for Prostate Cancer (PCA)	Placebo	-
Men at increased risk for Prostate Cancer (PCA)	Dutasteride	-

Primary Outcome Measures

Name	Time	Method
Cost of treating prostate-related events	REDUCE clinical trial, 4 year time period	Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis