Prostate Cancer Clinical Trial
Optimization of Prostate Biopsy – Micro-Ultrasound Versus MRI
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.
Full 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, the ExactVu High Resolution Micro-Ultrasound System, its safety details, and administrative details. It has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.
Eligibility Criteria
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
Exclusion Criteria:
History of prior prostate biopsy
History of genitourinary cancer, including prostate cancer
Contraindications to biopsy
Contraindications to mpMRI
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There are 6 Locations for this study
Gainesville Florida, 32611, United States
Toronto Ontario, M4N3M, Canada More Info
Principal Investigator
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