N/A
N=802
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05220501 ↗Enrolled (actual)
802
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy — 160; 141 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microultrasonography Targeted Biopsy (Diagnostic_test); MRI Targeted Biopsy (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Sunnybrook Health Sciences Centre
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Detection of Gleason Grade Group 2 or Higher Cancers Using Microultrasonography Plus Systematic Biopsy vs mpMRI/Conventional Ultrasonography Plus Systematic Biopsy |
160; 141 | <0.001 sig |
| SECONDARY Difference in csPCa Rate Between MicroUS/MRI- Guided Fusion Biopsy and MRI/Conventional Ultrasonography Guided Fusion Biopsy |
106; 141 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal Digital Rectal Examination
- 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
Exclusion Criteria
- History of prior prostate biopsy
- History of genitourinary cancer, including prostate cancer
- Contraindications to biopsy
- Contraindications to mpMRI
Data sourced from ClinicalTrials.gov (NCT05220501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.