Economic Analyses of the REDUCE Trial

Economic Analyses Alongside the REDUCE Clinical Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337258

Enrollment

Registered

2011-04-18

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostatic Hyperplasia, Cancer, Neoplasms, Prostate

Keywords

cost effectiveness, dutasteride, elevated risk population, Prostate cancer, prevention

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.

Interventions

DRUGDutasteride

dutasteride 0.5mg daily.

DRUGPlacebo

Men taking placebo daily

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026