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

February 26, 2024 updated by: Alessandro D'Agnolo

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

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM 1 (HIFU) - 18F-PSMA
10 mCi ±20% F18-PSMA injection

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint (HIFU):
Time Frame: 6 months following standard HIFU therapy
Negative biopsy rate on standard 12-core biopsy 6 months following HIFU therapy.
6 months following standard HIFU therapy
Secondary Endpoint (Prostatectomy):
Time Frame: 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.
6 months following standard HIFU therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Endpoint:
Time Frame: 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.
After study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

February 6, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 3, 2020

First Submitted That Met QC Criteria

July 6, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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