Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03964337
Status:
TERMINATED
Last Update Posted:
2022-06-29
First Post:
2019-05-23
Brief Title:
Immediate Prostatectomy vs Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Phase II Open-Label Randomized Study of Immediate Prostatectomy vs Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer SPARC
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief Summary:
This is a prospective randomized open-label phase II trial of cabozantinib in subjects with untreated high risk prostate cancer undergoing radical prostatectomy This multicenter study will enroll 30 subjects Duke is the lead site for this trial There will be a second site selected TBD
Patients will be assigned first 9 subjects only or randomized 21 to either 1 cabozantinib 40 mg by mouth daily for 4 weeks followed by a 2 week drug washout period before prostatectomy n 20 or 2 immediate prostatectomy within 12 weeks of registration n 10 The first 9 subjects 6 subjects assigned to cabozantinib treatment 3 subjects assigned to immediate prostatectomy will constitute the Safety Lead-In Cohort which will be only accrued at Duke After six subjects have received cabozantinib and completed the 57-85 day safety visit without triggering a stopping rule subjects may be accrued at the ex-Duke site
The primary goal is to compare pathologic apoptotic indices cleaved caspase-3 in prostatectomy specimens from patients who undergo immediate prostatectomy controls versus those who receive with cabozantinib followed by prostatectomy The secondary objective is to conduct immune phenotypic profiling on the peripheral blood and tumor microenvironment in prostatectomy specimens from both groups A statistical analysis will be used to compare the apoptotic indices between the two groups
Patients will be assigned first 9 subjects only or randomized 21 to either 1 cabozantinib 40 mg by mouth daily for 4 weeks followed by a 2 week drug washout period before prostatectomy n 20 or 2 immediate prostatectomy within 12 weeks of registration n 10 The first 9 subjects 6 subjects assigned to cabozantinib treatment 3 subjects assigned to immediate prostatectomy will constitute the Safety Lead-In Cohort which will be only accrued at Duke After six subjects have received cabozantinib and completed the 57-85 day safety visit without triggering a stopping rule subjects may be accrued at the ex-Duke site
The primary goal is to compare pathologic apoptotic indices cleaved caspase-3 in prostatectomy specimens from patients who undergo immediate prostatectomy controls versus those who receive with cabozantinib followed by prostatectomy The secondary objective is to conduct immune phenotypic profiling on the peripheral blood and tumor microenvironment in prostatectomy specimens from both groups A statistical analysis will be used to compare the apoptotic indices between the two groups
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None