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Updated: Jun 3, 2026
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Use of Magnetic Resonance Imaging and Biopsy Data to Guide Sampling Procedures for Prostate Cancer Biobanking
Published on: October 10, 2019
Biopsy misidentification identified by DNA profiling in a large multicenter trial.
Michael Marberger1, John D McConnell, Ivy Fowler
1Department of Urology, Medical University of Vienna, Waehringer Guertel 18-20, A-1090, Vienna, Austria. Michael.Marberger@A1.net
Summary
Biopsy sample misidentification occurred in the REDUCE trial, but DNA testing and improved handling reduced errors. Rigorous chain of custody and DNA testing are crucial for clinical trials.
Area of Science:
- Clinical trials
- Prostate cancer research
- Laboratory diagnostics
Background:
- The Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study investigated dutasteride's efficacy in reducing prostate cancer risk.
- Protocol-mandated biopsies were collected at years 2 and 4 for participants in the REDUCE study.
Purpose of the Study:
- To assess the incidence and impact of biopsy sample misidentification in a large, multinational clinical trial.
- To evaluate the effectiveness of DNA testing and process improvements in mitigating biopsy mismatches.
Main Methods:
- Retrospective and prospective DNA profiling of biopsy and blood samples from the REDUCE study.
- Implementation of enhanced sample handling and chain of custody procedures during year 2.
Main Results:
- Initial biopsy misidentification rates were 0.4% at year 2 and 0.02% at year 4.
- DNA profiling revealed 0.5% of reference blood samples were mismatched.
- Errors were identified at both local research sites and central laboratories.
Conclusions:
- Biopsy misidentification is an under-recognized issue in clinical trials and practice.
- Process improvements significantly reduced biopsy mismatches in the REDUCE study.
- Emphasized the need for strict chain of custody and consideration of widespread DNA identity testing.
