NCT05220501Completed
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
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.
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 804 (actual)
- First submitted
- 9 Dec 2021
- Start date
- 15 Dec 2021
- Primary completion date
- 6 Sept 2024
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- Prostate cancer
- NCT number
- NCT05220501
What you commit to
- Study type: Interventional
- Participants enrolled: 804
- From 15 Dec 2021 to the primary completion date, 6 Sept 2024
- 22 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior prostate biopsy
Other illness
- History of genitourinary cancer, including prostate cancer
Other
- Contraindications to biopsy
- Contraindications to mpMRI
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Elisabethinen Coordinator of this site? Confirm its status | Linz | Austria | Unknown status |
| Hopital Delta Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Hôpital du Sacré-Cœur de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hôpital Maisonneuve-Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| University Health Network, Princess Margaret Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| ProUro Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| University of Brandenburg Coordinator of this site? Confirm its status | Brandenburg an der Havel | Germany | Unknown status |
| University of Magdeburg Coordinator of this site? Confirm its status | Magdeburg | Germany | Unknown status |
| University of Tuebingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
| Urologica Clinica Bilbao Coordinator of this site? Confirm its status | Bilbao | Spain | Unknown status |
| Madrid ROC Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| ICUA Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Centre Hospitàlier Martigues, Hôpitaux de Provence Coordinator of this site? Confirm its status | Martigues | France | Unknown status |
| L Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Humanitas Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Florida Health Coordinator of this site? Confirm its status | Gainsville | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Carolina Urologic Research Center Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
Related publications
- External Validation of the PRI-MUS Scoring System: A Secondary Analysis of the OPTIMUM Randomized Controlled Trial.J Urol · 2026 · PMID 42048785
This page is information, not medical advice. Discuss any trial with your doctor.