Prostate Cancer Clinical Trial
High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
Summary
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
Full Description
This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.
Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.
Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.
Eligibility Criteria
Inclusion Criteria:
Biopsy consisting of ≥ 10 tissue cores sampled
PSA <20 ng/mL (for HIFU arm only)
cT1-cT2c
Either overall Gleason score > 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core (for HIFU arm only)
Patient considering focal HIFU therapy or robotic radical prostatectomy
Exclusion Criteria:
Previous local therapy for prostate cancer
Inability to receive PET tracer
Inability to receive MRI
Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2
Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
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