PSMA PET Scan and mpMRI for Prostate Cancer Detection

NCT ID: NCT05820724

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-05-01

Brief Summary

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.

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.

Conditions

Prostate Cancer Diagnosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSMA PET+mpMRI

PSMA PET+mpMRI guided prostate biopsy

Group Type: EXPERIMENTAL

PSMA PET scan

Intervention Type: DIAGNOSTIC_TEST

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.

18F- DCFPyl Injection

Intervention Type: DRUG

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.

mpMRI only

mpMRI only guided prostate biopsy

Group Type: ACTIVE_COMPARATOR

No PSMA PET

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

DCFPyL PET/CT imaging; DCFPyl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Aronson, MD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System

Locations

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Countries

United States

Central Contacts

William Aronson, MD

Role: CONTACT

william.aronson@va.gov

310-268-3446

Other Identifiers

1685514-1

Identifier Type: -

Identifier Source: org_study_id