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