PET/MRI with 18F-DCFPyL for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEdward M Schaeffer, MD PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Men with a PSA level of at least 2 ng/mL indicating potential prostate cancer, who are willing to undergo specific blood tests and biopsies as part of routine care. Participants must be over 18 years old and agree to use contraception for a day after imaging. Those with prior treatments, recent contrast medium use, past biopsies for prostate cancer, MRI contraindications like pacemakers, severely reduced kidney function or recent radioisotope administration cannot join.

Inclusion Criteria

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

I agree to have a PHI blood test and a prostate biopsy.

I am 18 years old or older.

+2 more

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

I haven't had a radioisotope treatment within its 5 half-lives before my PET/MRI scan.

+4 more

Participant Groups

The trial is testing the effectiveness of an imaging agent called 18F-DCFPyL in PET/MRI scans for diagnosing prostate cancer severity compared to multiparametric MRI alone. The study will assess how well this new method identifies tumor location and extent in men screened positive for prostate cancer.

1Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-DCFPyL PET/MRI, mpMRI)Experimental Treatment7 Interventions

Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.