PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Study Overview
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Brief Summary
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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.

Official Title
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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: 18F-DCFPyL


Participation Criteria
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Eligibility Criteria
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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 Patients must be age ≥ 18 years Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the 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 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 Patients may not be receiving any other treatments or investigational agents Patients with a GFR <30mL/min are ineligible to receive intravenous contrast per standard MR exclusion criteria Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral) Patients who have received androgen deprivation therapy or prior surgery for prostate cancer Patients who report taking multivitamins and/or folate supplements on the day of the scan

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DCFPyL<br> | Drug: 18F-DCFPyL<br>* To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer | To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone. | 5 years |