PSMA PET Scan and mpMRI for Prostate Cancer Detection

April 20, 2023 updated by: VA Greater Los Angeles Healthcare System

Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer

Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.

Study Type

Interventional

Enrollment (Anticipated)

100

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 Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • VA Greater Los Angeles Healthcare System
        • Principal Investigator:
          • William Aronson, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
  • Prostate mpMRI completed within 9 months prior to enrollment
  • Patient capable of providing written informed consent
  • Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT

Exclusion Criteria:

  • Less than 18 years-old at the time of radiotracer administration
  • Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
  • Creatinine clearance exceeding institutional requirements for prostate mpMRI

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSMA PET+mpMRI
PSMA PET+mpMRI guided prostate biopsy
Diagnostic test: PSMA PET scan
Subjects will undergo DCFPyL PET/CT imaging and mpMRI imaging prior to the prostate biopsy. The decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. The intervention includes a mpMRI, a PSMA PET scan, and a prostate biopsy.
Other Names:
  • DCFPyL PET/CT imaging
Drug: 18F- DCFPyl Injection
DCFPyL is a PSMA imaging ligand that was developed to enhance the detection of small lesions in the prostate or other pelvic areas. 18F- DCFPyl Injection will be administered prior to the PSMA PET/CT via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access under the direct supervision of study personnel.
Other Names:
  • DCFPyl
Active Comparator: mpMRI only
mpMRI only guided prostate biopsy
Other: No PSMA PET
Subjects will undergo mpMRI imaging prior to the prostate biopsy. These subjects do not undergo a PSMA PET scan prior to the prostate biopsy. The decision for biopsy targets will be made based on the findings of mpMRI. The intervention includes a mpMRI and a prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Clinically Significant Prostate Cancer
Time Frame: 12 weeks
Percentage of mpMRI and PSMA PET lesions positive for clinically significant prostate cancer
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Clinically Insignificant Prostate Cancer
Time Frame: 12 weeks
Percentage of mpMRI and PSMA PET lesions positive for clinically insignificant prostate cancer.
12 weeks
Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection
Time Frame: 12 weeks
Percentage of PSMA PET only (mpMRI negative) and PSMA PET overlapping with mpMRI lesions positive for clinically significant prostate cancer.
12 weeks
Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer
Time Frame: 12 weeks
Correlate intensity of PSMA PET lesions with clinically significant prostate cancer.
12 weeks
Correlation of AI Measures with Aggressiveness of Prostate Cancer
Time Frame: 12 weeks
Correlate artificial intelligence measurement(s) (miPSMA index) of PSMA lesion(s) with aggressiveness of prostate cancer
12 weeks
Adverse Events Associated with 18F- DCFPyl
Time Frame: 12 weeks
Safety - Patients will be monitored for adverse events during injection and for two hours after radiotracer administration.
12 weeks

Collaborators and Investigators

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

Sponsor

VA Greater Los Angeles Healthcare System

Collaborators

Lantheus Medical Imaging

Investigators

  • Principal Investigator: William Aronson, MD, VA Greater Los Angeles Healthcare System

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 (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1685514-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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