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NCT05613894 · ClinicalTrials.gov registry record · Phase 1
Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by University of Utah.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT05613894: Recruiting Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by University of Utah.
NCT05613894 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is actively recruiting participants, run by University of Utah. The registered enrollment target is 33 participants, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05613894, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is actively recruiting participants, sponsored by University of Utah.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the MTD and/or recommended dose and schedule for the subsequent expansion phase (Part 2).
Primary Outcome
To determine the maximum tolerated dose (MTD) and recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with metastatic castration-resistant prostate cancer (mCRPC) when taken in combination with 177Lu-PSMA-617
Conditions Studied
Interventions
- DRUG Cabozantinib
Study Locations (1)
Utah
- Huntsman Cancer Institute at University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2028-05-01 |
| Phase | Phase 1 |
What NCT05613894 shows while recruiting
NCT05613894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 197-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cabozantinib is the first listed.
NCT05613894 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05613894 about?
NCT05613894 is a clinical study titled "Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer". This is an open-label, phase 1b dose-escalation study of cabozantinib in combination with 177Lu-PSMA-617 in subjects with mCRPC. The primary hypothesis is that cabozantinib with 177Lu-PSMA will be safe and have efficacy in patients with mCRPC. The dose-escalation phase (Part 1) will assess the rate ...
What is the current status of trial NCT05613894?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2023-07-14. Estimated completion is 2028-05-01.
What conditions does trial NCT05613894 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT05613894?
The interventions under investigation include: Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT05613894?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05613894 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
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Where NCT05613894's enrollment target sits among peer trials
33 56th of 69 higher than 14 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant Prostate Cancer 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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