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Economic Analyses of the REDUCE Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337258
Recruitment Status : Completed
First Posted : April 18, 2011
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer Drug: Dutasteride Drug: Placebo

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Economic Analyses Alongside the REDUCE Clinical Trial
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dutasteride

Group/Cohort Intervention/treatment
Men at increased risk for Prostate Cancer (PCA) Drug: Dutasteride
dutasteride 0.5mg daily.
Other Name: Placebo

Drug: Placebo
Men taking placebo daily

Primary Outcome Measures :
  1. Cost of treating prostate-related events [ Time Frame: REDUCE clinical trial, 4 year time period ]
    Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01337258

Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT01337258    
Other Study ID Numbers: 113979
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by GlaxoSmithKline:
cost effectiveness
elevated risk population
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs