High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alessandro D'Agnolo
• Collaborator: Progenics Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Prostate biopsy consisting of ≥ 10 tissue cores sampled

• PSA
• 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.