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Trial Title:
PSMA PET Scan and mpMRI for Prostate Cancer Detection
NCT ID:
NCT05820724
Condition:
Prostate Cancer Diagnosis
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
psma PETCT
prostate mpMRI
prostate needle biopsy
DCFPyL PET/CT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
PSMA PET scan
Description:
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.
Arm group label:
PSMA PET+mpMRI
Other name:
DCFPyL PET/CT imaging
Intervention type:
Other
Intervention name:
No PSMA PET
Description:
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.
Arm group label:
mpMRI only
Intervention type:
Drug
Intervention name:
18F- DCFPyl Injection
Description:
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.
Arm group label:
PSMA PET+mpMRI
Other name:
DCFPyl
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
VA Greater Los Angeles Healthcare System
Address:
City:
Los Angeles
Zip:
90045
Country:
United States
Investigator:
Last name:
William Aronson, MD
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
May 1, 2026
Lead sponsor:
Agency:
VA Greater Los Angeles Healthcare System
Agency class:
U.S. Fed
Collaborator:
Agency:
Lantheus Medical Imaging
Agency class:
Industry
Source:
VA Greater Los Angeles Healthcare System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05820724
