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

NCT06391034 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 249225R01CA238379NCI-2024-03775
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Imaging Studies; Hyperpolarized 13C-Pyruvate

Outcome Measures

Primary Outcomes (7)

• Signal-to-noise ratio (Part 1)

  A signal-to-noise ratio is defined as a MR/spectroscopy parameter, consisting of the HP C13-Pyruvate or Lactate signal (peak) relative to background noise level (baseline) in MRI spectra of the tissue.

  Day of MR imaging (1 day)

• Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)

  The mean percent change in tumoral kPL between baseline and 1-year post-EBRT will be reported.

  Up to 24 months

• Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)

  The mean percent change in tumoral kPG between baseline and 1-year post-EBRT will be reported.

  Up to 24 months

• Mean change in on-treatment kPL over time (Part 2B)

  Mean percent change in tumoral kPL for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.

  Up to 24 months

• Mean change in on-treatment kPG over time (Part 2B)

  Mean percent change in tumoral kPG for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported.

  Up to 24 months

• Mean kPL at time of biochemical failure (Part 3)

  The mean kPL for participants with biochemical failure will be reported.

  Up to 24 months

• Mean kPG at time of biochemical failure (Part 3)

  The mean kPG for participants with biochemical failure will be reported.

  Up to 24 months

Secondary Outcomes (8)

• Intra-patient variability of kPL

  Up to 12 months

• Intra-patient variability of kPG

  Up to 12 months

• Mean intra-tumoral kPL above and below the median PSA (Parts 2-3) and the mean serum PSA

  Up to 24 months

• Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score

  Up to 24 months

• Correlation of kPG with PI-RADS version 2 classification score

  Up to 24 months

Study Arms (4)

Part 1: Image Optimization Group

EXPERIMENTAL

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.

Drug: hyperpolarized pyruvate +/-urea (13C/15N); Procedure: Multi-parametric magnetic resonance imaging (mpMRI)

Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants)

EXPERIMENTAL

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.

Drug: hyperpolarized pyruvate +/-urea (13C/15N); Radiation: Non-investigational External beam radiotherapy (EBRT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI)

Part 2B: Prospective imaging (High-risk localized prostate cancer)

EXPERIMENTAL

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.

Drug: hyperpolarized pyruvate +/-urea (13C/15N); Procedure: Radiotherapy (RT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI); Biological: Non-interventional hormone therapy

Part 3: EBRT participants at time of biochemical recurrence (BCR)

EXPERIMENTAL

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.

Drug: hyperpolarized pyruvate +/-urea (13C/15N); Radiation: Non-investigational External beam radiotherapy (EBRT); Procedure: Multi-parametric magnetic resonance imaging (mpMRI); Procedure: Prostate Biopsy

Interventions

hyperpolarized pyruvate +/-urea (13C/15N) DRUG

Given IV

Also known as: 13C-Pyruvate,15N-urea

Part 1: Image Optimization Group; Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants); Part 2B: Prospective imaging (High-risk localized prostate cancer); Part 3: EBRT participants at time of biochemical recurrence (BCR)

Non-investigational External beam radiotherapy (EBRT) RADIATION

External beam radiotherapy given outside of this study

Also known as: EBRT

Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants); Part 3: EBRT participants at time of biochemical recurrence (BCR)

Radiotherapy (RT) PROCEDURE

Radiation therapy given outside of this study

Also known as: RT

Part 2B: Prospective imaging (High-risk localized prostate cancer)

Multi-parametric magnetic resonance imaging (mpMRI) PROCEDURE

Imaging scan

Also known as: mpMRI

Part 1: Image Optimization Group; Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants); Part 2B: Prospective imaging (High-risk localized prostate cancer); Part 3: EBRT participants at time of biochemical recurrence (BCR)

Non-interventional hormone therapy BIOLOGICAL

Therapy given outside of this study as part of standard of care

Also known as: Non-interventional, systemic hormone therapy

Part 2B: Prospective imaging (High-risk localized prostate cancer)

Prostate Biopsy PROCEDURE

Biopsies may be taken from Trans-rectal ultrasound (TRUS) -visible lesion at the urologist's discretion

Also known as: Biopsy

Part 3: EBRT participants at time of biochemical recurrence (BCR)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review.
• For:
• Part 1: Participants post-radiation therapy or currently considering EBRT.
• Part 2A: Participants currently scheduled for or considering EBRT (no neo-adjuvant therapy planned).
• 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.
• 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.
• Participant is able and willing to comply with study procedures and provide signed and dated informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status \<= 1.
• Age \>= 18 years old at time of study entry.
• Ability to understand and the willingness to sign a written informed consent document.
• Demonstrates adequate organ function as defined below:
• White Blood Cell count (WBC) \>=4000 cells/μL.
• Hemoglobin ≥9.0 gm/dL.
• Platelets ≥75,000 cells/μL.
• Renal Function \> 30 Epithelial Growth Factor Receptor (eGFR).

You may not qualify if:

• 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).
• Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI.
• 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.
• 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).
• Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
• 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.

Sponsors & Collaborators

• Robert Bok, MD, PhD: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Robert Bok, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

(415) 502-1822; Louise.Magat@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 30, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): October 31, 2032
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)