Trial Information
Economic Analyses Alongside the REDUCE Clinical Trial
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Cost of treating prostate-related events
Outcome Description:
Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis
Outcome Time Frame:
REDUCE clinical trial, 4 year time period
Safety Issue:
No
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: No Health Authority
Study ID:
113979
NCT ID:
NCT01337258
Start Date:
January 2010
Completion Date:
July 2010
Related Keywords:
- Neoplasms, Prostate
- Benign Prostatic Hyperplasia
- Cancer
- cost effectiveness
- dutasteride
- elevated risk population
- Prostate cancer
- prevention
- Prostatic Hyperplasia
- Neoplasms
- Hyperplasia
- Prostatic Neoplasms