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NCT01529086 · ClinicalTrials.gov registry record
For Cause Prostate Biopsy in REDUCE Population Trial
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 6,608
- Enrollment target
NCT01529086: Completed study, sponsored by The Cleveland Clinic.
NCT01529086 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 6,608 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01529086 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 6,608 participants
- Enrollment target
Study Summary
The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer. For REDUCE, biopsies were defined as "protocol biopsy" if performed at certain timeframes, and "for cause" if outside these predetermined timeframes. The investigators propose a post hoc analysis that would allow them to include biopsies that really justified a clinical indication, but were excluded from "for cause" analysis based on occurring at either the 2 or 4 year timeframes. Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as: Group 1--dutasteride group biopsied "for cause" using several definitions: biopsy of patients who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a PSA rise\>0.2 ng/ml or who had a new abnormal DRE or had a free PSA\<12% . The investigators define these as such because this would reasonably instigate biopsy if the clinician had a patient with this scenario in the non-study setting. Group 2--placebo group biopsied "for cause" using several definitions, regardless of timeframe but reported at each year of the study and aggregate, with the aggregate number being the primary outcome. Thus the investigators would request results of biopsy of patients who received placebo To establish differences in biopsy positive rates the groups as per each definition listed, to determine if dutasteride decreased the likelihood of "for cause" biopsy compared to "not for cause" biopsy, and if there is a difference in cancer detection risk rate depending on cause vs. no cause in that group compared to placebo.
Primary Outcome
Determination of differences in cancer detection risk rate depending on cause vs no cause in that group compared to placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,608 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-02 |
What the finished NCT01529086 record still lists
NCT01529086 is an observational study that tracks outcomes without assigning an intervention. Its 6,608 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01529086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01529086 about?
NCT01529086 is a clinical study titled "For Cause Prostate Biopsy in REDUCE Population Trial". The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% ...
What is the current status of trial NCT01529086?
This trial is currently completed. The enrollment target is 6,608 participants. The study started on 2012-02. Estimated completion is 2012-02.
Who is sponsoring clinical trial NCT01529086?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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