PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2028-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This phase II trial studies how well 18F-DCFPyL positron emission tomography (PET)/magnetic resonance imaging (MRI) works for the diagnosis of prostate cancer in men with a PSA greater than or equal to 2 ng/mL. 18F-DCFPyl is a radioactive injectable imaging agent made of a prostate specific membrane antigen (PSMA) that attaches to tumor cells, which makes it useful for the diagnosis of prostate cancer. A PET scan is an imaging tool that may help find the location of cancer, by using a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. A mp-MRI is used to help determine the extent of a patient's cancer. A MRI scan uses strong magnets and computers to create detailed images of the soft tissue in the body. This trial aims to compare PET scans to prostate specific mp-MRI to evaluate prostate cancer severity in men with a positive screen for prostate cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fluorides

Criteria

Inclusion Criteria:

• Patients must have a positive screen for prostate cancer as confirmed by a prostate specific antigen (PSA) >= 2 ng/ml

• Patients must elect to elect to undergo PHI blood test and TRUS-guided elect to undergo PHI blood test and TRUS-guided biopsy as part of routine clinical care

• Patients must be age >= 18 years

• Patients must agree to use adequate contraception (e.g. Barrier method of birth control; abstinence) for 24 hours following completion of imaging

• Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

• Patients who have had a prior biopsy for prostate cancer

• Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible

• Patients receiving any other treatments or investigational agents are not eligible

• Patients with a glomerular filtration rate (GFR) < 30mL/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria

• Patients administered a radioisotope < 5 physical half-lives prior to the date of study PET/MRI

• Patients administered IV X-ray contrast medium < 120 hours prior to the date of study PET/MRI

• Patients who report taking multivitamins on the day of study PET/MRI