Last updated: 11/07/2018 07:05:17
Economic Analyses of the REDUCE Trial
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Economic Analyses Alongside the REDUCE Clinical Trial
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Cost of treating prostate-related events
Timeframe: REDUCE clinical trial, 4 year time period
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Kattan MW, Earnshaw SR, McDade CL, Black LK, Andriole GL. Cost Effectiveness of Chemoprevention for Prostate Cancer with Dutasteride in a High-Risk Population Based on Results from the REDUCE Clinical Trial. [Appl Health Econ Health Policy]. 2011;9(5):305-315.
Medical condition
Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
Product
dutasteride
Collaborators
Not applicable
Study date(s)
January 2010 to October 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
50 - 75 years
Accepts healthy volunteers
No
- 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)
- 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
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2010-28-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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