Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT03964337
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Cabozantinib 40 mg by mouth daily for 4 weeks.
  • Radical Prostatectomy — PROCEDURE
    Radical prostatectomy as part of routine medical care.

Study Details

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.

Key Dates

Start date
Mar 17, 2020
Status verified
Jun 2022
Primary completion
Jun 4, 2021
Completion
Jun 4, 2021

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cabozantinib Followed by Prostatectomy (Arm A)
    Experimental group will received cabozantinib for 4 weeks, followed by a 2 week drug washout before a prostatectomy.
  • Active Comparator: Immediate Prostatectomy (Arm B)
    Control group will receive an immediate prostatectomy.

Primary Outcome Measure

Apoptotic Index in Prostatectomy Specimens From Patients Who Undergo Immediate Prostatectomy (Arm B) Versus Those Treated With Cabozantinib Followed by Prostatectomy (Arm A) [ Time Frame: At prostatectomy (Arm A: Day 43, Arm B: Day 1) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Duke University Medical Center· Durham, NC

Related Studies