Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Localized Prostate Cancer

Status Recruiting

Clinical Trial Summary

This is a single site, prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen (pH) values in surrounding tissue. The proposed study will evaluate pre-surgical participants with histologically confirmed localized prostate cancer who receive infusion of hyperpolarized 13C injection prior to MR imaging with endorectal coil.

Clinical Trial Description

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 OBJECTIVES:

I. To correlate the measurement of tissue pH with pathologic grade.

II. To correlate tissue pH maps with immunohistochemistry staining (IHC), gene expression (RNA-Seq), and spatial transcriptomics. *Bristol Myers Squibb (BMS) collaboration

OUTLINE:

Men with biopsy-proven adenocarcinoma of the prostate scheduled to undergo radical prostatectomy at University of California, San Francisco (UCSF) within 12 weeks of enrollment will receive infusion with hyperpolarized 13C bicarbonate and undergo metabolic MR imaging with endorectal coil. Participants will be followed for 5-9 days after the hyperpolarized 13C-bicarbonate injection, or removal from study, or until death, whichever occurs first. Participants removed from study for unacceptable study related adverse event(s) will be followed until resolution or stabilization (as determined by the investigator) or until initiation of new anti-cancer therapy, whichever occurs first. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05851365
• Study type: Interventional
• Source: University of California, San Francisco
• Contact: Maya Aslam
• Phone: (415) 514-8987
• Email: Maya.Aslam@ucsf.edu
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 6, 2023
• Completion date: December 31, 2025