Status:
COMPLETED
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Exact Imaging
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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.
Detailed Description
The purpose of the Clinical Investigation Plan and Study Protocol is to present information for the OPTIMUM clinical investigation, including the scientific basis for the study, the procedural details...
Eligibility Criteria
Inclusion
- 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
- History of prior prostate biopsy
- History of genitourinary cancer, including prostate cancer
- Contraindications to biopsy
- Contraindications to mpMRI
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT05220501
Start Date
December 15 2021
End Date
September 6 2024
Last Update
November 7 2025
Active Locations (22)
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1
UCLA
Los Angeles, California, United States, 90095
2
Yale University
New Haven, Connecticut, United States, 06511
3
University of Florida Health
Gainsville, Florida, United States, 32611
4
Johns Hopkins
Baltimore, Maryland, United States, 21205