Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384222
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-04-22
Brief Title:
Hyperpolarized HP 13C Pyruvate Magnetic Resonance Imaging MRI for Response Monitoring to Neoadjuvant Abiraterone
Sponsor:
Ivan de Kouchkovsky MD
Organization:
University of California San Francisco
Study Overview
Official Title:
Hyperpolarized HP 13C Pyruvate Magnetic Resonance Imaging MRI As a Response Monitoring Tool in Patients with High-Risk Prostate Cancer Receiving Neoadjuvant Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the use of hyperpolarized 13C MRI HP 13C MRI and the HP-derived 13C pyruvate-to-lactate conversion rate constant kPL as an early response biomarker in men with treatment-naïve high-risk localized or locally advanced prostate cancer receiving neoadjuvant therapy
Detailed Description:
PRIMARY OBJECTIVE
I To investigate on-treatment changes in HP 13C MRI derived kPL as an early response biomarker in men with high-risk localized or locally advanced prostate cancer receiving neoadjuvant abirateroneprednisone prior to radical prostatectomy RP
SECONDARY OBJECTIVES
I To evaluate the pathologic complete responseminimal residual disease rate at the time of radical prostatectomy following 12 weeks of neoadjuvant abirateroneprednisone in patients with high-risk localized or locally advanced prostate cancer
II To determine the safety and tolerability of neoadjuvant abirateroneprednisone in patients with high-risk localized or locally advanced prostate cancer planning to undergo radical prostatectomy RP
III To assess time to biochemical recurrence following radical prostatectomy after 12 weeks of neoadjuvant abirateroneprednisone IV To assess prostate-specific antigen PSA response to neoadjuvant abirateroneprednisone prior to RP
EXPLORATORY OBJECTIVES
I To assess the diagnostic performances of multiparametric MRI mpMRI and hyperpolarized 13C MRI HP13C MRI for pathological response at the time of RP II To investigate the association between early changes in intratumoral metabolism HP 13C derived pyruvate-to-lactate conversion rate kPL on neoadjuvant abiraterone with PSA nadir III To evaluate associations between baseline genomic and transcriptional features changes in intratumoral kPL and pathologic response at the time of radical prostatectomy
OUTLINE
Participants will receive 12 weeks of neoadjuvant abirateroneprednisone After completion of neoadjuvant therapy participants will proceed to radical prostatectomy Participants will be followed for up to 5 years every 3 months for the first year following RP then every 6 months until death biochemical recurrence or initiation of additional prostate cancer directed therapy
I To investigate on-treatment changes in HP 13C MRI derived kPL as an early response biomarker in men with high-risk localized or locally advanced prostate cancer receiving neoadjuvant abirateroneprednisone prior to radical prostatectomy RP
SECONDARY OBJECTIVES
I To evaluate the pathologic complete responseminimal residual disease rate at the time of radical prostatectomy following 12 weeks of neoadjuvant abirateroneprednisone in patients with high-risk localized or locally advanced prostate cancer
II To determine the safety and tolerability of neoadjuvant abirateroneprednisone in patients with high-risk localized or locally advanced prostate cancer planning to undergo radical prostatectomy RP
III To assess time to biochemical recurrence following radical prostatectomy after 12 weeks of neoadjuvant abirateroneprednisone IV To assess prostate-specific antigen PSA response to neoadjuvant abirateroneprednisone prior to RP
EXPLORATORY OBJECTIVES
I To assess the diagnostic performances of multiparametric MRI mpMRI and hyperpolarized 13C MRI HP13C MRI for pathological response at the time of RP II To investigate the association between early changes in intratumoral metabolism HP 13C derived pyruvate-to-lactate conversion rate kPL on neoadjuvant abiraterone with PSA nadir III To evaluate associations between baseline genomic and transcriptional features changes in intratumoral kPL and pathologic response at the time of radical prostatectomy
OUTLINE
Participants will receive 12 weeks of neoadjuvant abirateroneprednisone After completion of neoadjuvant therapy participants will proceed to radical prostatectomy Participants will be followed for up to 5 years every 3 months for the first year following RP then every 6 months until death biochemical recurrence or initiation of additional prostate cancer directed therapy
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 |
|---|---|---|---|
| NCI-2024-03418 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |