Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT06391034
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.
Detailed Description:
PRIMARY OBJECTIVES:
I. Part 1: To Optimize the imaging sequences that maximize signal-to-noise ratio (SNR) and intra-tumoral kPL and kPG in regions of tumor vs. adjacent benign tissue as assessed by mpMRI imaging characteristics.
II. Part 2A To perform HP 13C-MRI and measure the changes in tumoral kPL and kPG.
III. Part 2B: To perform HP 13C-MRI and study the metabolic effects (changes in tumor kPL and kPG).
IV. Part 3: To perform HP 13C-MRI at time of Biochemical Failure and measure tumoral kPL and kPG, in previously SBRT treated patients.
SECONDARY OBJECTIVES:
I. To evaluate the intra-patient variability in intra-tumoral kPL and kPG with repeated dose studies (Part 1, 2 \& 3).
II. To determine the association between peak intra-tumoral kPL observed on baseline imaging with serum PSA. (Part 2 \& 3).
III. To determine the association between changes in intra-tumor kPL after 4-12 weeks of systemic hormone therapy and PSA response (Part 2B).
IV. To compare and contrast intra-tumoral kPL and kPG with Prostate Imaging Reporting and Data System (PI-RADS) version 2 and individual mpMRI parameters including apparent diffusion coefficient (ADC) on diffusion-weighted imaging (Part 1, 2 \& 3).
V. To describe the frequency of up-grading of tumor with MR/US-guided fusion biopsy obtained following baseline HP-MRI exam. (Part 3).
VI. To further characterize the safety profile of HP C-13 pyruvate injections (Part 1, 2 \& 3).
VII. For patients imaged with HP 13C-MRI at time of biochemical failure post-SBRT, correlate peak intra-tumoral kPL and kPG with radiotherapy dose distributions from SBRT course (Part 3).
VIII. For studies incorporating HP 13C-urea, the baseline and the on-treatment changes in ureaAUC parameter will be measured and compared to kPL endpoints of the same lesions (Part 1, 2 \& 3).
OUTLINE:
The study is divided into 3 parts. Part 1: Participants undergo imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam to determine exact parameters for imaging.
Part 2A: Participants planned for stereotactic body radiotherapy (SBRT) Part 2B: Participants with high-risk localized prostate cancer planned to receive primary radiation therapy with concurrent systemic hormone therapy Part 3: Evaluable SBRT participants scanned at time of biochemical failure and MR/US fusion-guided prostate biopsy within 12 weeks. Participants have the option of undergoing a follow up HP Pyruvate +/- Urea MR exam 6-15 months following the baseline scan.
All participants will receive a scan at baseline and other procedures may be performed as part of routine, non-interventional standard of care at the time of biochemical failure, including serial prostate-specific antigen (PSA) monitoring and gene expression profiling of tumor tissue. Participants will be followed for 24 months after last procedure or removal from study, or until death, whichever occurs first.
Study:
NCT06391034
Study Brief:
Protocol Section:
NCT06391034