Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06391034

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

Led by Robert Bok, MD, PhD · Updated on 2026-01-07

161

Participants Needed

1

Research Sites

422 weeks

Total Duration

On this page

Sponsors

R

Robert Bok, MD, PhD

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy-proven adenocarcinoma of the prostate
  • Participants post-radiation therapy or considering external beam radiotherapy (EBRT) (Part 1)
  • Participants scheduled for EBRT without planned neo-adjuvant therapy (Part 2A)
  • Participants with high-risk prostate cancer (tumor stage T3 or T4, Gleason score 8-10, or PSA 60 ng/mL) scheduled for EBRT and planned androgen deprivation therapy with LHRH agonist or antagonist; androgen-receptor signaling inhibitors allowed (Part 2B)
  • Participants previously treated with radiation and showing biochemical failure with planned fusion biopsy within 12 weeks of baseline HP 13C MRI (Part 3)
  • Able and willing to comply with study procedures and provide informed consent
  • ECOG performance status 61
  • Age 18 years or older
  • Adequate organ function: WBC 64000 cells/bcL, Hemoglobin 69.0 gm/dL, Platelets 675,000 cells/bcL, Renal function eGFR > 30
Not Eligible

You will not qualify if you...

  • Evidence of pelvic regional or distant metastatic disease on conventional or PSMA PET imaging (except PSMA-avid lymph nodes <1 cm confined to pelvis)
  • Prostate biopsy within 14 days before baseline HP 13C pyruvate MRI
  • Poorly controlled hypertension (blood pressure >160 mm Hg systolic or >100 mm Hg diastolic) at study entry
  • Contraindications or inability to tolerate MRI with endorectal coil (e.g., severe claustrophobia, cardiac pacemaker, aneurysm clip, severe hemorrhoids, rectal stricture)
  • Congestive heart failure with NYHA status 62
  • History of significant ECG abnormalities including QT prolongation, family history of prolonged QT syndrome, or myocardial infarction within 6 months before study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

L

Louise Magat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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