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TerminatedPhase 2

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

Reason given: Funding ceased before all specimen collection and analysis could be completed

Key facts

Where
Los Angeles, United StatesSee the site
Phase
Phase 2

Where in United States

  • Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part

Trial details

Who runs it
Alessandro D'Agnolo
Trial code
NCT04461509
Record updated
22 July 2026
Original description
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.Read full original descriptionShow less

High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy

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.

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; Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial; Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2; Inability to receive PET tracer; Inability to receive MRI.

ClinicalTrials.gov NCT04461509