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

Phase 2

Completed

• Conditions: Genital Diseases, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Neoplasms; Genital Neoplasms, Male; Prostatic Disease
• Interventions: Drug: 18F-PSMA

• Registration Number: NCT04461509
• Lead Sponsor: Alessandro D'Agnolo

Brief 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.

Detailed Description

This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Study Timeline

• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-08
• Study Start: 2021-04-06
• Primary Completion: 2024-02-06
• Study Completion: 2024-09-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 59

Inclusion Criteria

1. Biopsy consisting of ≥ 10 tissue cores sampled
2. PSA <20 ng/mL (for HIFU arm only)
3. cT1-cT2c
4. 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)
5. Patient considering focal HIFU therapy or robotic radical prostatectomy

Exclusion Criteria

1. Previous local therapy for prostate cancer
2. Inability to receive PET tracer
3. Inability to receive MRI
4. Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2
5. Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM 2 (RP) - 18F-PSMA	18F-PSMA	10 mCi ±20% F18-PSMA injection
ARM 1 (HIFU) - 18F-PSMA	18F-PSMA	10 mCi ±20% F18-PSMA injection

Primary Outcome Measures

Name	Time	Method
Primary Endpoint (HIFU):	At time of post-imaging biopsy, 6 months following standard HIFU therapy	Number of additional biopsy-proven cancers that novel imaging modalities of hrMRI and/or F18-PSMA PET would detect when compared to reference standard imaging of mpMRI in patients undergoing HIFU procedure.
Primary Endpoint (Prostatectomy):	preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery	To determine the sensitivity in detection of prostatic carcinoma of novel imaging modalities of hrMRI and/or F18-PSMA PET compared to reference standard mpMRI in patients scheduled to undergo radical prostatectomy.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint (HIFU):	6 months following standard HIFU therapy	Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.
Secondary Endpoint (Prostatectomy):	6 months following standard HIFU therapy	Specificity of hrMRI, F18-PSMA PET and mpMRI for detecting all tumors and metastasis at 6 months follow up.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States