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

Launched by NORTHWESTERN UNIVERSITY · May 27, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new way to detect prostate cancer using a special imaging technique called PSMA-targeted PET/MRI. The trial focuses on men who have a positive screening for prostate cancer, indicated by a prostate-specific antigen (PSA) level of 2 ng/mL or higher. The goal is to see how well this imaging method works in identifying the presence and severity of prostate cancer, which may help doctors better understand the disease and plan treatment.

To be eligible for the trial, participants must be men aged 18 or older with a confirmed positive prostate cancer screening. They should be willing to undergo certain tests as part of their routine care, including a blood test and a biopsy. However, men who have had a previous biopsy for prostate cancer or cannot undergo an MRI due to medical devices like pacemakers are not eligible. If you join the trial, you can expect to receive the imaging tests, which will involve a combination of a PET scan (using a small amount of radioactive material to see how your body is working) and an MRI (which uses magnets to take detailed images of your body). This trial is not yet recruiting participants, so more information will be available as it progresses.

Gender

MALE

Eligibility 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