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Economic Analyses of the REDUCE Trial

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms, Prostate; Benign Prostatic Hyperplasia; Cancer

Intervention: Dutasteride (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline


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.

Clinical Details

Official title: Economic Analyses Alongside the REDUCE Clinical Trial

Study design: Observational Model: Cohort, Time Perspective: Retrospective

Primary outcome: Cost of treating prostate-related events


Minimum age: 50 Years. Maximum age: 75 Years. Gender(s): Male.


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

Locations and Contacts

Additional Information

Starting date: January 2010
Last updated: April 14, 2011

Page last updated: August 20, 2015

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