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

Sponsor
Alessandro D'Agnolo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04461509
Collaborator
Progenics Pharmaceuticals, Inc. (Industry)
80
1
2
35.8
2.2

Study Details

Study Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)Patients are identified by investigator and enrolled in Arm 1 (HIFU) or Arm 2 (RP)
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
High-Resolution, 18F-PSMA PET-MRI for Mapping Prostate Cancer in Patients Considering Focal High-Intensity Focused Ultrasound (HIFU) Therapy or Radical Prostatectomy
Actual Study Start Date :
Apr 6, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARM 1 (HIFU) - 18F-PSMA

10 mCi ±20% F18-PSMA injection

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
Other Names:
  • 18F-DCFPyL Injection
  • Experimental: ARM 2 (RP) - 18F-PSMA

    10 mCi ±20% F18-PSMA injection

    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
    Other Names:
  • 18F-DCFPyL Injection
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Secondary Endpoint (HIFU): [6 months following standard HIFU therapy]

      Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.

    2. 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.

    Other Outcome Measures

    1. Exploratory Endpoint: [After study completion, an average of 6 months]

      RNAseq transcriptome analysis of lesions that are positive on mapping biopsy. Sensitivity and specificity of PET-hrMRI for detecting all tumors detected on prostatectomy pathology.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States 90048

    Sponsors and Collaborators

    • Alessandro D'Agnolo
    • Progenics Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Alessandro D'Agnolo, MD, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alessandro D'Agnolo, Co-Director Nuclear Medicine, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT04461509
    Other Study ID Numbers:
    • STUDY00000832
    First Posted:
    Jul 8, 2020
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alessandro D'Agnolo, Co-Director Nuclear Medicine, Cedars-Sinai Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2022