Clinical trial NCT05852041: rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance
Official title: 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
Conditions: Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
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.
Interventions:
description: Undergo MRI/PET prostate biopsy
name: Biopsy of Prostate
other_name: Prostate Biopsy
Prostatic Biopsy
type: Procedure
description: Undergo decipher
name: Decipher Prostate Cancer Test
other_name: Decipher
Decipher Metastasis Test
Decipher Test
type: Genetic
description: Given IV
name: Flotufolastat F-18 Gallium
other_name: (18F)-rhPSMA-7.3
18F-rhPSMA-7.3
18FrhPSMA-7.3
F-18-rhPSMA-7.3
Fluorine F 18 radiohybrid PSMA-7.3
Fluorine F 18 rhPSMA-7.3
Fluorine-18 rhPSMA-7.3
rhPSMA-7.3 (18F)
type: Other
description: Undergo PET-MRI
name: Magnetic Resonance Imaging
other_name: MR
MR Imaging
MRI
MRI Scan
Magnetic Resonance
Magnetic Resonance Imaging Scan
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
NMR Imaging
NMRI
Nuclear Magnetic Resonance Imaging
type: Procedure
description: Undergo mpMRI
name: Multiparametric Magnetic Resonance Imaging
other_name: MP-MRI
Multi-parametric MRI
Multiparametric MRI
mpMRI
type: Procedure
description: Undergo PET-MRI
name: Positron Emission Tomography
other_name: Medical Imaging, Positron Emission Tomography
PET
PET Scan
PT
Positron Emission Tomography Scan
Positron-Emission Tomography
proton magnetic resonance spectroscopic imaging
type: Procedure
description: Undergo radical prostatectomy
name: Radical Prostatectomy
other_name: Prostatovesiculectomy
type: Procedure
Study arms:
design_group_description: Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
design_group_title: Treatment (rhPSMA, PET-MRI, mpMRI)
design_group_type: Experimental
Sponsor: Northwestern University
Collaborators: National Cancer Institute
Drug name mappings:
name: 氟[18F]妥司特
lang: CN
name: Flotufolastat F-18
lang: EN