Imaging prostate cancer using hyperpolarized carbon compounds

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy

This study is testing a new type of MRI using special carbon compounds to see if it can help doctors better understand and track prostate cancer in patients before and after radiation therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 161 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of California, San Francisco (other)
• Drugs / interventions: radiation
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT06391034 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical study investigates the use of hyperpolarized 13C-pyruvate and 15N-urea in metabolic magnetic resonance imaging (MRI) for patients with prostate cancer. The study aims to optimize imaging sequences to enhance signal quality and assess metabolic changes in tumors compared to surrounding tissue. It includes multiple parts focusing on imaging before and after radiation therapy, evaluating intra-tumoral metabolic activity, and correlating imaging findings with serum PSA levels. The safety profile of hyperpolarized carbon injections will also be characterized throughout the study.

Who should consider this trial

Good fit: Ideal candidates are patients with biopsy-proven adenocarcinoma of the prostate who are undergoing or considering radiation therapy.

Not a fit: Patients with non-adenocarcinoma prostate cancer or those not planning to undergo radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer imaging and treatment monitoring, leading to better patient outcomes.

How similar studies have performed: Other studies using hyperpolarized imaging techniques have shown promise, suggesting potential for success in this novel application.

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.

Where this trial is running

San Francisco, California

• University of California, San Francisco — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Robert Bok, MD, PhD — University of California, San Francisco
• Study coordinator: Louise Magat

Conditions: Prostate Cancer, Imaging Studies, Hyperpolarized 13C-Pyruvate