Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391034
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
Magnetic Resonance MR Imaging With Hyperpolarized 13C-Pyruvate - 13C15N-Urea in Patients With Prostate Cancer
Sponsor:
Robert Bok MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase 2 Study of Magnetic Resonance MR Imaging With Hyperpolarized 13C-Pyruvate - 13C15N-Urea in Patients With Prostate Cancer Undergoing Radiation Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 clinical study of hyperpolarized HP 13C-pyruvate 13C 15N-urea 13C15N 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 MRUS-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 MRUS 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
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 MRUS-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 MRUS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01CA238379 | NIH | None | httpsreporternihgovquickSearch5R01CA238379 |