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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hyperplasia
Prostatic Hyperplasia
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on November 27, 2014