Economic Analyses Alongside the REDUCE Clinical Trial
N/A
50 Years
75 Years
50 Years
75 Years
Not Enrolling
Male
Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
Male
Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
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
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