Economic Analyses of the REDUCE Trial

NCT01337258 | Completed

• 1 other identifier: 113979
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasms, Prostate; Benign Prostatic Hyperplasia; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cost of treating prostate-related events

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

  REDUCE clinical trial, 4 year time period

Study Arms (1)

Men at increased risk for Prostate Cancer (PCA)

Drug: Dutasteride; Drug: Placebo

Interventions

Dutasteride DRUG

dutasteride 0.5mg daily.

Also known as: Placebo

Men at increased risk for Prostate Cancer (PCA)

Placebo DRUG

Men taking placebo daily

Men at increased risk for Prostate Cancer (PCA)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia; Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: April 18, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 30, 2017

Record last verified: 2017-05