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NCT03964337 · ClinicalTrials.gov registry record · Phase 2
Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03964337: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT03964337 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03964337, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
Apoptotic index as measured by cleaved caspase-3 levels in tumor tissue
Interventions
- PROCEDURE Radical Prostatectomy
- DRUG Cabozantinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-03-17 |
| Est. Completion | 2021-06-04 |
| Phase | Phase 2 |
Why NCT03964337 stopped before completion
NCT03964337 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Radical Prostatectomy is the first listed.
NCT03964337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03964337 about?
NCT03964337 is a clinical study titled "Immediate Prostatectomy vs. Cabozantinib Followed by Prostatectomy in Men With High-Risk Prostate Cancer". 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. Patie...
What is the current status of trial NCT03964337?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-03-17. Estimated completion is 2021-06-04.
What interventions are being tested in trial NCT03964337?
The interventions under investigation include: Radical Prostatectomy (PROCEDURE), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT03964337?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03964337's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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