Phase 2 N=62 Other

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

Prostatic Neoplasms · Genital Neoplasms, Male · Urogenital Neoplasms · Neoplasms by Site · Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT04461509 ↗

Enrolled (actual)

Serious AEs

8.9%

Results posted

May 2025

Primary outcome: Primary: Primary Endpoint (HIFU): Identification of New Cancers — 85; 49 biopsy-proven cancerous zones

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18F-PSMA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Alessandro D'Agnolo
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Endpoint (HIFU): Identification of New Cancers	85; 49	—
PRIMARY Primary Endpoint (HIFU):	8	—
SECONDARY Secondary Endpoint (HIFU):	17; 18	—
SECONDARY Secondary Endpoint (Prostatectomy):	—	—

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.

Eligibility Criteria

Inclusion Criteria

Biopsy consisting of ≥ 10 tissue cores sampled
PSA 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04461509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.