Economic Analyses of the REDUCE Trial

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.

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Key information

Conditions

Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

dutasteride 0.5mg daily.

Other names: Placebo

Placebo

Drug

Men taking placebo daily

Primary outcomes

Cost of treating prostate-related events

Time frame: REDUCE clinical trial, 4 year time period

Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Economic Analyses Alongside the REDUCE Clinical Trial

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Apr 18, 2011
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed