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For Cause Prostate Biopsy in REDUCE Population Trial

NCT01529086 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6608

Last updated 2016-08-23

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Stephen Jones, MD · The Cleveland Clinic

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01529086 on ClinicalTrials.gov