A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy
Robert Bok, MD, PhD
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.
Description
PRIMARY OBJECTIVES: I. Part 1: To Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral kPL and kPG in regions of tumor vs. adjacent benign tissue as assessed by mpMRI imaging characteristics. II. Part 2A To perform HP 13C-MRI and measure the changes in tumoral kPL and kPG. III. Part 2B: To perform HP 13C-MRI and study the metabolic effects (changes in tumor kPL and kPG). IV. Part 3: To perform HP 13C-MRI at time of Biochemical Failure and measure tumoral kPL and kPG, in previously external beam radiation therapy (EBRT) treated patients. SECONDARY OBJE…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review. 2. For: 1. Part 1: Participants post-radiation therapy or currently considering EBRT. 2. Part 2A: Participants currently scheduled for or considering EBRT (no neo-adjuvant therapy planned). 3. Part 2B: Participants currently scheduled for or considering EBRT and neo-adjuvant therapy is planned. The participant has biopsy-proven adenocarcinoma of the prostate with high-risk disease, defined by the presence of at least two of following criteria: a tumor st…
Interventions
- Drughyperpolarized pyruvate +/-urea (13C/15N)
Given IV
- RadiationNon-investigational External beam radiotherapy (EBRT)
External beam radiotherapy given outside of this study
- ProcedureRadiotherapy (RT)
Radiation therapy given outside of this study
- ProcedureMulti-parametric magnetic resonance imaging (mpMRI)
Imaging scan
- BiologicalNon-interventional hormone therapy
Therapy given outside of this study as part of standard of care
- ProcedureProstate Biopsy
Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion
Location
- University of California, San FranciscoSan Francisco, California