This clinical trials evaluates 18F-fluciclovine positron emission tomography (PET)/magnetic resonance imaging (MRI) in diagnosing patients with prostate cancer that has come back after radiation therapy (radio-recurrent). Diagnostic procedures such as 18F-fluciclovine PET/MRI may help doctors better find where the cancer may be present.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05035732.
PRIMARY OBJECTIVE:
I. To compare the diagnostic performance of fluciclovine F18 (18F-fluciclovine) pelvic PET/MRI to that of pelvic
multiparametric (mp)MRI and to determine whether 18F-fluciclovine pelvic PET/MRI is more accurate than a pelvic mpMRI in detecting pelvic radio-recurrent prostate cancer (RRPC) in men with biochemical recurrence with histopathology as reference standard.
SECONDARY OBJECTIVE:
I. To study inter-reader reliability of 18F-fluciclovine pelvic PET/MRI and pelvic mpMRI among the readers.
EXPLORATORY OBJECTIVE:
I. To study correlation between SUVmax and ADCmean in the pelvic RRPC.
OUTLINE:
Patients receive fluciclovine F18 intravenously (IV) and undergo PET/MRI over 60 minutes. Patients also undergo standard of care mpMRI.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorDevaki Shilpa Sudha Surasi
