A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Northwestern University
Summary
This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.
Description
PRIMARY OBJECTIVE: I. Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease. A threshold rate of 15% detection will be considered clinically significant. SEONDARY OBJECTIVE: I. Assessment of safety. EXPLORATORY OBJECTIVES: I. Determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups. II. Correlate PET MRI findings with surgical specimens for those men who undergo surgical…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy men (Eastern Cooperative Oncology Group \[ECOG\] 0-1), \>= 18 years old with at least 10 year life expectancy * Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate * Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed by prior mpMRI * Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \[PSA\] \< 10ng/ml, Gleason Grade Gr…
Interventions
- ProcedureBiopsy of Prostate
Undergo MRI/PET prostate biopsy
- GeneticDecipher Prostate Cancer Test
Undergo decipher
- OtherFlotufolastat F-18 Gallium
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo PET-MRI
- ProcedureMultiparametric Magnetic Resonance Imaging
Undergo mpMRI
- ProcedurePositron Emission Tomography
Undergo PET-MRI
- ProcedureRadical Prostatectomy
Location
- Northwestern UniversityChicago, Illinois