Economic Analyses of the REDUCE Trial

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT01337258

Collaborator

(none)

Enrollment

5.9

Duration (Months)

Study Details

Study Description

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	Phase
Neoplasms, Prostate Benign Prostatic Hyperplasia Cancer	Drug: Dutasteride Drug: Placebo

Study Design

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 :

Jan 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Men at increased risk for Prostate Cancer (PCA)	Drug: Dutasteride dutasteride 0.5mg daily. Other Names: Placebo Drug: Placebo Men taking placebo daily

Arm

Intervention/Treatment

Men at increased risk for Prostate Cancer (PCA)

Drug: Dutasteride

dutasteride 0.5mg daily.

Other Names:

Placebo

Drug: Placebo

Men taking placebo daily

Outcome Measures

Primary Outcome Measures

Cost of treating prostate-related events [REDUCE clinical trial, 4 year time period]
Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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