Cancer Clinical Trial
Official title:
Economic Analyses Alongside the REDUCE Clinical Trial
Verified date | May 2017 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
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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