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.
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 Group 1 [Gleason 3+3=6] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 [Gleason score 3+4=7])
Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
NCCN very low risk category (T1c and Gleason Grade Group 1 [Gleason score 3+3=6], PSA < 10 ng/mL, fewer than 3 prostate biopsy cores positive, =< 50% cancer in any core, PSA density < 0.15 ng/mL/g)
Decipher score < 0.45
Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], Urolift, Rezum)
Single group
Biopsy of Prostate
Procedure/SurgeryUndergo MRI/PET prostate biopsy
Decipher Prostate Cancer Test
GeneticUndergo decipher
Flotufolastat F-18 Gallium
Other interventionGiven IV
Magnetic Resonance Imaging
Procedure/SurgeryUndergo PET-MRI
Multiparametric Magnetic Resonance Imaging
Procedure/SurgeryUndergo mpMRI
Positron Emission Tomography
Procedure/SurgeryUndergo PET-MRI
Radical Prostatectomy
Procedure/SurgeryUndergo radical prostatectomy
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Will report agreement between pathology and imaging and ability of radiohybrid prostate-specific membrane antigen-7-PET-MRI to identify higher grade and stage disease as a raw percentage.
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]
Occurrence of severe adverse events occurring following imaging will be reported as a percentage. Will use the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.
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Northwestern University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
