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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

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.

Interventions

  • Drug: 18F-PSMA
    • Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA) Other Names: 18F-DCFPyL Injection prostate-cancer-specific radiotracer

Arms, Groups and Cohorts

  • Experimental: 18F-PSMA
    • 10 mCi ±20% F18-PSMA injection

Clinical Trial Outcome Measures

Primary Measures

  • Difference between sensitivities to identify prostate lesions.
    • Time Frame: At time of post-imaging biopsy, 6 months following standard HIFU therapy
    • Number of biopsy-proven cancers that standard imaging (mpMRI) would have missed compared with high resolution diffusion-weighted imaging (DWI) PET-hrMRI on mapping MRI.

Secondary Measures

  • Negative biopsy rate
    • Time Frame: 6 months following standard HIFU therapy
    • Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the negative biopsy rate in the treated region.
  • Rate of high grade cancer
    • Time Frame: 6 months following standard HIFU therapy
    • Following the tumor mapping study, patients with high grade disease (i.e. Gleason grade 4 or 5) in one lobe undergo hemigland or focal HIFU of that lobe. Patients would then undergo repeat prostate biopsy to assess the absence of Gleason grade 4 or 5 in the untreated region.

Participating in This Clinical Trial

Inclusion Criteria

  • Prostate biopsy consisting of ≥ 10 tissue cores sampled – PSA </=20 ng/mL – 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 – Patient considering focal HIFU therapy Exclusion Criteria:

  • Previous local therapy for prostate cancer – Inability to receive PET tracer – Inability to receive MRI – Suggestion of extracapsular extension or seminal vesicle invasion on imaging – Estimated glomerular filtration rate (GFR) <45 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.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alessandro D’Agnolo
  • Collaborator
    • Progenics Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Alessandro D’Agnolo, Co-Director Nuclear Medicine – Cedars-Sinai Medical Center
  • Overall Official(s)
    • Alessandro D’Agnolo, MD, Principal Investigator, Cedars-Sinai Medical Center
  • Overall Contact(s)
    • Jenny Park, MPH, 310-423-8762, Jenny.park@cshs.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.