Fluorine F 18 DCFPyL PET/MRI in Diagnosing Participants with Stage I-IV Prostate Cancer

Status: closed to accrual

This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to created detailed images of the soft tissue in your body. The purpose of this study is to gain understanding 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. We will compare the results of PET/MR images after giving you the contrast agent with the images of a mp-MRI which will be taken during the same scan as the PET/MR as part of your routine prostate cancer care. The results of both the mp-MRI and PET/MR will be compared to the cancer tissue taken during your prostate cancer surgery. All of the scans performed in this study are considered standard of care for prostate cancer. This research study involves the use of a scanner that is capable of taking PET and MR images at the same time. A PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how organs and tissues in the body are functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working. A MR scan uses strong magnets and computers to create detailed images of the soft tissue in your body. The purpose of this study is to gain understanding 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. We will compare the results of PET/MR images after giving you the contrast agent with the images of a mp-MRI which will be taken during the same scan as the PET/MR as part of your routine prostate cancer care. The results of both the mp-MRI and PET/MR will be compared to the cancer tissue taken during your prostate cancer surgery. All of the scans performed in this study are considered standard of care for prostate cancer.

Inclusion Criteria

Patients must have a biopsy-proven diagnosis of prostate cancer
Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines (T3-T4 disease)
Patients are healthy enough to be deemed surgical candidates with an Eastern Cooperative Oncology Group (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 24 hours 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) are not eligible
Patients who are claustrophobic are not eligible. However, patients who are willing to participate are required to take anti-anxiety medication as prescribed by their physician
Patients receiving any other treatments or investigational agents are not eligible
Patients with a glomerular filtration rate (GFR) < 30 ml/min are ineligible to receive intravenous contrast per standard magnetic resonance (MR) exclusion criteria
Patients not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral) are not eligible
Patients who have received androgen deprivation therapy or prior surgery for prostate cancer are not eligible
Patients who report taking multivitamins and/or folate supplements on the day of the scan are not eligible

PRIMARY OBJECTIVE:

I. To determine if PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to multi-parametric magnetic resonance imaging (mp-MRI) alone.

SECONDARY OBJECTIVES:

I. To explore the clinical utility of [18F]-DCFPyL in PET/MRI for imaging of newly diagnosed prostate cancer.

II. To monitor cancer prostate cancer progression, recurrence and overall survival in patients undergoing PET/MRI for staging of newly diagnosed prostate cancer 5 years from the start of study treatment.

OUTLINE:

Patients receive fluorine F 18 DCFPyL intravenously (IV) and then undergo simultaneous mp-MRI and PET/MRI scan of their prostate over approximately 4 hours.

After completion of study, patients are followed up at 30 days and then periodically for up to 5 years.

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Fluorine F 18 DCFPyL PET/MRI in Diagnosing Participants with Stage I-IV Prostate Cancer

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