Status:
COMPLETED
High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
Lead Sponsor:
Alessandro D'Agnolo
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Prostatic Neoplasms
Genital Neoplasms, Male
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-PSMA PET-MRI) will detect prostate cancers not seen on standard ...
Detailed 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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04461509
Start Date
April 6 2021
End Date
September 3 2024
Last Update
May 29 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048