Economic Analyses of the REDUCE Trial

NCT ID: NCT01337258

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Men at increased risk for Prostate Cancer (PCA)

Dutasteride

Intervention Type DRUG

dutasteride 0.5mg daily.

Placebo

Intervention Type DRUG

Men taking placebo daily

Interventions

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Dutasteride

dutasteride 0.5mg daily.

Intervention Type DRUG

Placebo

Men taking placebo daily

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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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

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

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113979

Identifier Type: -

Identifier Source: org_study_id

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