PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
Reason given: Study aborted
Key facts
- Where
- Chicago, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Northwestern UniversityChicago, United StatesNo longer taking part
Trial details
- Who runs it
- Northwestern University
- Trial code
- NCT04910425
- Record updated
- 21 October 2025
- Original description
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.Read full original descriptionShow less
Phase II Study to Evaluate the Performance of PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Clinically Significant Prostate Cancer in Men Presenting Following a Positive Screen for Prostate Cancer
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.
Inclusion: 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: Patients who have had a prior biopsy for prostate cancer; Patients receiving any other treatments or investigational agents are not eligible; 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 with a glomerular filtration rate (GFR) < 30mL/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria; Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) are not eligible; Patients who report taking multivitamins on the day of study PET/MRI.