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NCT01337258 Clinical Trial

Economic Analyses of the REDUCE Trial

Cancer Clinical Trial

Official title:
Economic Analyses Alongside the REDUCE Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01337258
Other study ID # 113979
Secondary ID
Status Completed
Phase N/A
First received March 4, 2010
Last updated May 25, 2017
Start date January 2010
Est. completion date July 2010

Study information
Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dutasteride
dutasteride 0.5mg daily.
• Placebo
Men taking placebo daily

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary Cost of treating prostate-related events Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis REDUCE clinical trial, 4 year time period
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