CompletedPhase 2

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

United States62 participantsStarted 2021-04-06

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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 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.

What they're measuring

Primary Endpoint (HIFU): Identification of New Cancers

Timeframe: At time of pre-HIFU biopsy

Primary Endpoint (HIFU):

Timeframe: preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery

Trial details

NCT IDNCT04461509

SponsorAlessandro D'Agnolo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-03

Results submitted2025-01-20

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