Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Completed · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05220501

Run by

Sunnybrook Health Sciences Centre

People needed

804

Starts

2021-12-15

Expected to finish

2024-09-06

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• History of prior prostate biopsy
• History of genitourinary cancer, including prostate cancer
• Contraindications to biopsy
• Contraindications to mpMRI

Where it is running

• UCLA — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida Health — Gainsville, Florida, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Ordensklinikum Elisabethinen — Linz, Austria
• Hopital Delta — Brussels, Belgium
• University of Alberta — Edmonton, Alberta, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• University Health Network - Princess Margaret Hospital — Toronto, Ontario, Canada
• Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Hôpital du Sacré-Cœur de Montréal — Montreal, Quebec, Canada
• Centre Hospitàlier Martigues, Hôpitaux de Provence — Martigues, France
• L'Institut Mutualiste Montsouris — Paris, France
• University of Brandenburg — Brandenburg an der Havel, Brandenburg, Germany
• University of Magdeburg — Magdeburg, Saxony-Anholt, Germany
• ProUro — Berlin, Germany
• University of Tuebingen — Tübingen, Germany
• Humanitas — Milan, Italy
• Urologica Clinica Bilbao — Bilbao, Spain
• Madrid ROC — Madrid, Spain
• ICUA Madrid — Madrid, Spain

Full record on ClinicalTrials.gov

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