PET/MRI for Prostate Cancer

Overseen By Mary Kate Keeter, MPH

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Anti-anxiety, Multivitamins

Disqualifiers: MRI contraindications, Low GFR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

48 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.

Research Team

Edward Schaeffer, MD/PhD

Principal Investigator

Chair, Department of Urology

Eligibility Criteria

This trial is for men over 18 with high risk or advanced prostate cancer, confirmed by biopsy. They must be fit enough for surgery (ECOG status 0-2) and willing to use contraception during the study. Excluded are those with poor kidney function, MRI contraindications like pacemakers, claustrophobia not managed by medication, vitamin supplements on scan day, prior prostate cancer treatments, or no interest in surgical treatment.

Inclusion Criteria

Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer

Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease)

Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2

Exclusion Criteria

Patients with a GFR <30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria

Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments)

Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MRI using 18F-DCFPyL to assess prostate cancer staging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 18F-DCFPyL

Trial Overview The study tests PET-MRI using a tracer called 18F-DCFPyL (PyL) to improve diagnosis and staging of prostate cancer before surgery. It aims to understand how this imaging technique can better identify the extent of the disease compared to traditional methods.

Participant Groups

Group I: 18F-DCFPyL Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Progenics Pharmaceuticals, Inc.

Industry Sponsor

Trials

35

Recruited

4,400+