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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 SBRT.

⁃ Part 2A: Participants currently scheduled for or considering SBRT (no neo-adjuvant therapy planned).

⁃ Part 2B: Participants currently scheduled for or considering SBRT 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).

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Louise Magat
Louise.Magat@ucsf.edu
(415) 502-1822
Time Frame
Start Date: 2024-09-24
Estimated Completion Date: 2032-10-31
Participants
Target number of participants: 161
Treatments
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 (Stereotactic body radiotherapy (SBRT) Participants)
Participants with pre-planned, non-interventional stereotactic body radiotherapy (SBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-SBRT 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: SBRT participants at time of biochemical recurrence (BCR)
Evaluable SBRT 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.
Related Therapeutic Areas
Sponsors
Leads: Robert Bok, MD, PhD
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov