Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
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 2:1 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.