This early phase I trial tests the safety and side effects of hyperpolarized 13C bicarbonate prior to magnetic resonance imaging (MRI) in measuring tissue pH in localized prostate carcinoma. Measuring the tumor pH, or its acidity, may help doctors determine the severity of the prostate cancer. Knowing the tumor pH levels may also determine whether the prostate cancer will spread, and which treatment regimens will be most effective in managing localized prostate cancer. Diagnostic procedures, such as 13C MRI, may help doctors learn how tumor pH predicts prostate cancer severity to allow doctors to plan better treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT05851365.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Temporarily closed to accrual
Contact: Robert Flavell
Phone: 415-353-3638
PRIMARY OBJECTIVE:
I. To determine the feasibility of tumor pH measurement in men with prostate cancer using hyperpolarized 13C bicarbonate imaging.
SECONDARY OBJECTIVE:
I. To determine the safety of administration of hyperpolarized 13C bicarbonate.
EXPLORATORY OBJECTIVE:
I. To correlate the measurement of tissue pH with pathologic grade.
II. To correlate tissue pH maps with immunohistochemistry staining (IHC), gene expression (ribonucleic acid [RNA]-sequencing [Seq]), and spatial transcriptomics.
OUTLINE:
Patients receive gadolinium intravenously (IV) and undergo standard MRI, as well as endorectal coil placement on study. Patients then receive hyperpolarized 13C bicarbonate IV and undergo dynamic 13C MRI on study. Patients also undergo standard of care radical prostatectomy with tissue sampling within 12 weeks after MRI on study.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorRobert Flavell