Clinical trial NCT05820724: PSMA PET Scan and mpMRI for Prostate Cancer Detection
Official title: Prostate Specific Membrane Antigen (PSMA) Scan and Multiparametric MRI for Prostate Biopsy Detection of Clinically Significant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Diagnosis
Keywords: psma PETCT
prostate mpMRI
prostate needle biopsy
DCFPyL PET/CT
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: Lantheus Medical Imaging
First posted: 2023-04-20
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Detection of Clinically Significant Prostate Cancer
timeFrame: 12 weeks
Secondary outcomes:
measure: Detection of Clinically Insignificant Prostate Cancer
timeFrame: 12 weeks
measure: Difference in PSMA PET and mpMRI Clinically Significant Cancer Detection
timeFrame: 12 weeks
measure: Correlation of PSMA PET intensity with Clinically Significant Prostate Cancer
timeFrame: 12 weeks
measure: Correlation of AI Measures with Aggressiveness of Prostate Cancer
timeFrame: 12 weeks
measure: Adverse Events Associated with 18F- DCFPyl
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: William Aronson, MD
role: PRINCIPAL_INVESTIGATOR
References: