Status:
COMPLETED
High Resolution PET-MRI Before Prostate Cancer HIFU
Lead Sponsor:
Timothy J. Daskivich
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 s...
Detailed Description
This is a prospective trial to evaluate the effectiveness of 18F-fluciclovine PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy. Participants with clinically loc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03263780
Start Date
December 7 2017
End Date
January 8 2020
Last Update
February 21 2021
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048