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

- 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