Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorIvan de Kouchkovsky, MD
About this trial
This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue
Eligibility criteria
Qualifiers
Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.
Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.
Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.
The participant is able and willing to comply with study procedures and provide signed and dated informed consent
Disqualifiers
Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.
Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
Trial design
Treatments tested in this trial
- Hyperpolarized 13C-Pyruvate
- Hyperpolarized 13C,15N2-urea
- Magnetic Resonance Spectroscopic Imaging
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ivan de Kouchkovsky, MD
Lead sponsor
University of California, San Francisco
Sponsor institution
American Cancer Society, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
Source ClinicalTrials.gov