Who is sponsoring NCT05613894?

NCT05613894 is sponsored by University of Utah.

What drugs are being tested in NCT05613894?

Interventions in NCT05613894: Cabozantinib.

What condition does NCT05613894 study?

NCT05613894 studies Metastatic Castration-resistant Prostate Cancer.

Is NCT05613894 still recruiting?

NCT05613894 is currently recruiting now. Last updated 31 October 2025.

Last reviewed 2025-10-31 · How we verify

NCT05613894: CaboLu

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dose-Escalation Study of Cabozantinib in Combination With Lutetium-177 (177Lu)-PSMA-617 in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting now Phase 1 Last updated 31 October 2025

What this trial tests

Phase 1 trial testing Cabozantinib in Metastatic Castration-resistant Prostate Cancer in 33 participants. Currently enrolling.

Timeline

14 July 2023

Primary endpoint
1 May 2026

1 May 2028

Quick facts

Lead sponsor	University of Utah
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	33
Start date	14 July 2023
Primary completion	1 May 2026
Estimated completion	1 May 2028
Sites	1 location across United States

Drugs / interventions tested

Cabozantinib (CABOZANTINIB) — full drug profile →

Conditions studied

Metastatic Castration-resistant Prostate Cancer — all drugs for Metastatic Castration-resistant Prostate Cancer →

Sponsor

University of Utah

Who can join

18 and older, male only, with Metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Intensification Approaches and Treatment Sequencing in Metastatic Castration-resistant Prostate Cancer: A Systematic Review.
Francini E, Agarwal N, Castro E, Cheng HH, et al · · 2025 · cited 21× · PMID 39306478 · DOI 10.1016/j.eururo.2024.09.008
Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey.
McManus HD, Dorff T, Morgans AK, Sartor O, et al · · 2025 · cited 14× · PMID 39420184 · DOI 10.1038/s41391-024-00906-z
Current clinical application of lutetium‑177 in solid tumors (Review).
Niu T, Fan M, Lin B, Gao F, et al · · 2024 · cited 13× · PMID 38596660 · DOI 10.3892/etm.2024.12514
Prostate-Specific Membrane Antigen-Targeted Therapy in Prostate Cancer: History, Combination Therapies, Trials, and Future Perspective.
Mattana F, Muraglia L, Barone A, Colandrea M, et al · · 2024 · cited 9× · PMID 38730595 · DOI 10.3390/cancers16091643
The therapeutic use of 177 Lu-PSMA-617 radioligand therapy in prostate cancer treatment: a review of literature and ongoing trials.
Konopnicki A, Zaliznyak M, Roy M, Jana B. · · 2024 · cited 5× · PMID 39692806 · DOI 10.1007/s12672-024-01680-z

Verify or expand the search:

Other trials of Cabozantinib

Trials testing the same drug.

NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz · Phase 1, PHASE2 · recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell · Phase 1 · not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent · Phase 2 · recruiting

Other recruiting trials for Metastatic Castration-resistant Prostate Cancer

Currently open trials in the same condition.

NCT07142551 — Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response · Phase 2 · recruiting
NCT07288359 — Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and · Phase 1, PHASE2 · recruiting
NCT07244341 — A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer ( · Phase 1 · recruiting
NCT07213674 — A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic · Phase 3 · recruiting
NCT07189403 — A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Carcinoma and Metastatic Castration-resist · Phase 1 · recruiting

Other University of Utah trials

Trials by the same sponsor.

NCT07515755 — Supplemental Oxygen and Oxygen Desaturations in Colonoscopies · NA · not yet recruiting
NCT07225426 — Personalizing Financial Incentives · NA · recruiting
NCT06716411 — Confirming the Effects of Acupuncture Treatments to Relieve Symptoms of Gulf War Illness · NA · recruiting
NCT07246538 — Positive Airway Pressure (PAP) System Evaluation in Volunteers · NA · not yet recruiting
NCT04208984 — Diversion Device With Breath Control · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05613894 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Utah
Last refreshed: 31 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05613894.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing