Economic Analyses of the REDUCE Trial

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01337258
First received: March 4, 2010
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Neoplasms, Prostate
Benign Prostatic Hyperplasia
Cancer
Drug: Dutasteride
Drug: Placebo

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Economic Analyses Alongside the REDUCE Clinical Trial

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cost of treating prostate-related events [ Time Frame: REDUCE clinical trial, 4 year time period ] [ Designated as safety issue: No ]
    Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis


Enrollment: 1
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Men at increased risk for Prostate Cancer (PCA) Drug: Dutasteride
dutasteride 0.5mg daily.
Other Name: Placebo
Drug: Placebo
Men taking placebo daily

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337258

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01337258     History of Changes
Other Study ID Numbers: 113979
Study First Received: March 4, 2010
Last Updated: April 14, 2011
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
cost effectiveness
dutasteride
elevated risk population
Prostate cancer
prevention

Additional relevant MeSH terms:
Prostatic Hyperplasia
Neoplasms
Hyperplasia
Prostatic Neoplasms
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014