Economic Analyses of the REDUCE Trial

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Neoplasms, Prostate; Benign Prostatic Hyperplasia; Cancer

Treatments: Drug: Dutasteride; Drug: Placebo

Study type: Observational

Funder types: Industry

Identifiers

NCT01337258

113979

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Male

Ages: 50 to 75 years old

Volunteers: No 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 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

Trial design

1 participants in 1 patient group

Men at increased risk for Prostate Cancer (PCA)

Treatment:

Drug: Placebo

Drug: Dutasteride