Overview
High Resolution PET-MRI Before Prostate Cancer HIFU
Status:
Completed
Completed
Trial end date:
2020-01-08
2020-01-08
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-fluciclovine PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Timothy J. DaskivichCollaborator:
Blue Earth Diagnostics
Criteria
Inclusion Criteria:- Prostate biopsy consisting of ≥ 10 tissue cores sampled
- PSA =20 ng/mL
- 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
- Patient considering focal HIFU therapy
Exclusion Criteria:
- Previous local therapy for prostate cancer
- Inability to receive PET tracer
- Inability to receive MRI
- Suggestion of extracapsular extension or seminal vesicle invasion on imaging
- Estimated creatinine clearance <45 mL/min (Cockcroft-Gault equation)
- Any other condition which, in the investigator's option, may make the patient a poor
candidate for participation in a clinical trial.