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

Stopped early · Phase 2

Conditions studied: Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Neoplasms, Genital Diseases, Male, Prostatic Disease

In brief

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.

Key facts

Study ID

NCT04461509

Run by

Alessandro D'Agnolo

People needed

62

Starts

2021-04-06

Expected to finish

2024-09-03

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.