This phase II trial tests whether the addition of a new MRI technique called RSI + T2WI can detect prostate cancer better than a standard of care MRI. Diagnostic procedures such as RSI + T2WI in addition to standard of care prostate MRI may help identify other sites of disease.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05046782.
PRIMARY OBJECTIVE:
I. To compare the diagnostic accuracy of T2 weighted imaging (T2WI) and restriction spectrum imaging (RSI) (T2WI + RSI) to that of multiparametric magnetic resonance imaging (MRI) (mpMRI), for the detection of individual prostate cancer foci.
SECONDARY OBJECTIVE:
I. To perform a pilot study evaluating T2WI+RSI/ultrasound (US) fusion guided biopsy compared to mpMRI/US fusion biopsy for the diagnosis of clinically significant cancer (any Gleason grade group > 2) in a cohort of patients scheduled for clinically indicated MRI/US fusion guided biopsy.
EXPLORATORY OBJECTIVES:
I. To acquire high frequency transrectal microultrasound data in patients undergoing clinically indicated MRI/US fusion guided biopsy.
II. To perform additional comparative analyses of mpMRI and RSI images, including analyzing variations in tumor contours between imaging data sets.
OUTLINE:
Patients undergo T2WI+RSI and mpMRI over 30-90 minutes. Patients may also undergo T2WI+RSI/US fusion guided biopsy and mpMRI/US fusion biopsy.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAradhana M. Venkatesan
