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: 2024-09-03
• Study Completion: 2024-09-03
• Results First Submitted: 2025-01-20
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Results First Posted: 2025-05-29
• Last Update Posted: 2025-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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): Identification of New Cancers	At time of pre-HIFU biopsy	The grade of the cancer is assessed by biopsy prior to HIFU. Systematic and targeted prostate biopsies assess presence or absence of cancer in each zone of the prostate, including both systematic and targeted zones. Each zone with cancer is graded using the Gleason score (range 6-10, with higher scores associated with more aggressive disease). The primary outcome is for detection of any additional cancer with advanced imaging techniques of hrMRI or PSMA-PET MRI over standard multiparametric MRI. Any cancer is defined as "Gleason 6 or higher." We also did an exploratory analysis looking at detection of additional cancers with Gleason scores of 7 or higher.
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 systematic and targeted biopsy 6 months following HIFU therapy. Data presented are from both systematic + targeted biopsy as a single unit. For example, a positive biopsy from a given area of the prostate could have come from either systematic or targeted cores.
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