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

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy

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

Intervention / Treatment
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* Drug: 18F-PSMA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1 (HIFU) - 18F-PSMA<br>10 mCi ±20% F18-PSMA injection | Drug: 18F-PSMA<br>* Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer<br>* Other names: 18F-DCFPyL Injection;|
| Experimental: ARM 2 (RP) - 18F-PSMA<br>10 mCi ±20% F18-PSMA injection | Drug: 18F-PSMA<br>* Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer<br>* Other names: 18F-DCFPyL Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint (HIFU): | 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. | At time of post-imaging biopsy, 6 months following standard HIFU therapy | 
| Primary Endpoint (Prostatectomy): | 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. | preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic imaging, High-Intensity Focused Ultrasound, HIFU, 18F-PSMA, high resolution diffusion-weighted imaging