Optimization of Prostate Biopsy – Micro-Ultrasound Versus MRI (OPTIMUM)
Contact information
Laurence Klotz, Dr
University of Alberta
Edmonton, Alberta, Canada, T6G1Z1
Basic information
N/A
N/A Age
1200 Enrollment
Trial Details
Brief Summary
OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.
Official Title
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: A 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men With Clinical Suspicion of Prostate Cancer.
Selection Criteria
Eligibility Inclusion Criteria
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- Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE
- No history of prior prostate biopsy
- No history of genitourinary cancer, including prostate cancer
- 18 years or older
- No contraindications to biopsy
- No contraindications to mpMRI
- No history of mpMRI for clinical investigation of prostate cancer within 12 months prior to screening and enrollment in the study
Eligibility Exclusion Criteria
-
- History of prior prostate biopsy
- History of genitourinary cancer, including prostate cancer
- Contraindications to biopsy
- Contraindications to mpMRI
