The Role of 68Ga-PSMA-11 PET in MRI Fusion Biopsy and Surgery Guidance in Prostate Cancer
Clinton Bahler, MD
Primary Investigator
Overview
The overall objective of this Early Phase Clinical Trial is to begin defining the accuracy of 68Ga-PSMA-11 for detecting the location and size of clinically significant prostate cancer lesions in low and intermediate risk disease.
Description
A molecularly-targeted probe (68Ga-PSMA-11), coupled with an advanced clinical imaging system (Siemens Biograph VisionPET-CT), will improve accuracy during biopsy and staging. We propose detailed intra-lesion whole-mount pathologic analysis as the gold standard for critically assessing PSMA PET accuracy in patients undergoing surgery, and blinded PSMA PET-CT comparison with standard multi-parametric MRI (mpMRI) for patients having biopsy on active surveillance. This intensive testing of the accuracy and value of PSMA-based tracers requires our unique collaboration of surgeons, radiologists, pathologists, and imaging scientists with decades of experience and innovation.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Prostate Cancer
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Age: Between 18 Years - 100 Years
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Gender: Male
Inclusion Criteria
Presence of low or intermediate risk prostate cancer on prostate biopsy.
Scheduled for prostate biopsy, focal treatment or surgical removal of prostate
Willing and able to lie still for approximately 50 minutes in an enclosed space for the standard of care mpMRI
Exclusion Criteria
Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed).
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.