Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
NCT06391034 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 161
Last updated 2026-01-07
Summary
This is a Phase 2 clinical study of hyperpolarized (HP) 13C-pyruvate (13C), 15N-urea (13C,15N) metabolic MR imaging in prostate cancer patients who are undergoing or have received radiation therapy for prostate cancer.
Conditions
Interventions
- BIOLOGICAL
-
Non-interventional hormone therapy
Therapy given outside of this study as part of standard of care
- PROCEDURE
-
Prostate Biopsy
Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion
- PROCEDURE
-
Radiotherapy (RT)
Radiation therapy given outside of this study
- PROCEDURE
-
Multi-parametric magnetic resonance imaging (mpMRI)
Imaging scan
- DRUG
-
hyperpolarized pyruvate +/-urea (13C/15N)
Given IV
- RADIATION
-
Non-investigational External beam radiotherapy (EBRT)
External beam radiotherapy given outside of this study
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Robert Bok, MD, PhD
lead OTHER
Principal Investigators
-
Robert Bok, MD, PhD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-24
- Primary Completion
- 2028-12-31
- Completion
- 2032-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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