Economic Analyses of the REDUCE Trial

GlaxoSmithKline1 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer

Interventions

DutasterideDRUG

dutasteride 0.5mg daily.

PlaceboDRUG

Men taking placebo daily

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cost of treating prostate-related events

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

Time frame: REDUCE clinical trial, 4 year time period

Data from ClinicalTrials.gov

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