Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Robert Bok, MD, PhD
Study ID
NCT06391034
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • hyperpolarized pyruvate +/-urea (13C/15N) — DRUG
    Given IV
  • Non-investigational External beam radiotherapy (EBRT) — RADIATION
    External beam radiotherapy given outside of this study
  • Radiotherapy (RT) — PROCEDURE
    Radiation therapy given outside of this study
  • Multi-parametric magnetic resonance imaging (mpMRI) — PROCEDURE
    Imaging scan
  • Non-interventional hormone therapy — BIOLOGICAL
    Therapy given outside of this study as part of standard of care
  • Prostate Biopsy — PROCEDURE
    Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion

Study Details

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.

Key Dates

Start date
Sep 24, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
161 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Part 1: Image Optimization Group
    Participants will undergo Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam, with the primary objective of optimizing imaging sequences and techniques to maximize signal-to-noise ratio of imaging modality.
  • Experimental: Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants)
    Participants with pre-planned, non-interventional stereotactic body radiotherapy (EBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-EBRT treatment and at 1yr post-treatment.
  • Experimental: Part 2B: Prospective imaging (High-risk localized prostate cancer)
    Participants with with high-risk localized prostate cancer and have pre-planned, non-interventional primary radiation therapy (RT) with concurrent, systemic, non-interventional hormone therapy will undergo HP Pyruvate+/-Urea mpMRI at baseline prior to the start of systemic hormone therapy, 4-12 weeks after the initiation of systemic hormone therapy (prior to radiation therapy), at 3 months post-radiation therapy, and at +1yr post-radiation therapy.
  • Experimental: Part 3: EBRT participants at time of biochemical recurrence (BCR)
    Evaluable EBRT participants who undergo HP Pyruvate +/-Urea mpMRI at time of biochemical failure, followed by magnetic resonance (MR) / ultrasound (US) fusion-guided prostate biopsy within 12 weeks following baseline MR exam. Participants in this group have the option of undergoing a follow up HP Pyruvate +/-Urea MR exam 6-15 months following the baseline scan, to evaluate for any interval change.

Primary Outcome Measure

Signal-to-noise ratio (Part 1) [ Time Frame: Day of MR imaging (1 day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Louise Magat
[email protected]
(415) 502-1822
[email protected]
877-827-3222
Robert Bok, MD, PhD (PRINCIPAL_INVESTIGATOR)
Anthony Wong, MD, PhD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CA

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