NCT06391034 Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
| NCT ID | NCT06391034 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Robert Bok, MD, PhD |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 161 participants |
| Start Date | 2024-09-24 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 161 participants in total. It began in 2024-09-24 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 stage of T3 or T4, a Gleason score of 8 to 10, or a PSA level ≥40 ng/mL) and the participant must be planning to receive androgen deprivation therapy (ADT) with an Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist. The addition of an androgen-receptor (AR) signaling inhibitor (e.g., abiraterone, bicalutamide,apalutamide, enzalutamide or darolutamide) will be allowed. 4. Part 3: Participants who have previously received radiation treatment to the prostate and are exhibiting signs of biochemical failure, with planned fusion biopsy within 12 weeks following completion of baseline HP 13C pyruvate +/-urea mpMRI. 3. Participant is able and willing to comply with study procedures and provide signed and dated informed consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 1. 5. Age \>= 18 years old at time of study entry. 6. Ability to understand and the willingness to sign a written informed consent document. 7. Demonstrates adequate organ function as defined below: 1. White Blood Cell count (WBC) \>=4000 cells/μL. 2. Hemoglobin ≥9.0 gm/dL. 3. Platelets ≥75,000 cells/μL. 4. Renal Function \> 30 Epithelial Growth Factor Receptor (eGFR). Exclusion Criteria: 1. Evidence of pelvic regional or distant metastatic disease on conventional imaging (MRI, computed tomography or whole body bone scan) or prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) imaging. PSMA-avid lymph nodes confined to the pelvis will be allowed if \<1 centimeter (cm). 2. Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI. 3. Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mm Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted. 4. Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture). 5. Congestive heart failure with New York Heart Association (NYHA) status \>= 2. 6. History of clinically significant ECG abnormality, including QT prolongation, a family history of prolonged QT interval syndrome or myocardial infarction within 6 months of study entry.
Contact & Investigator
Robert Bok, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06391034 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06391034 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06391034 currently recruiting?
Yes, NCT06391034 is actively recruiting participants. Contact the research team at Louise.Magat@ucsf.edu for enrollment information.
Where is the NCT06391034 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06391034 clinical trial?
NCT06391034 is sponsored by Robert Bok, MD, PhD. The principal investigator is Robert Bok, MD, PhD at University of California, San Francisco. The trial plans to enroll 161 participants.
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