Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04446117 · ClinicalTrials.gov registry record · Phase 3
Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC
A Phase 3 study of Prostate Adenocarcinoma and Metastatic Prostate Cancer, sponsored by Exelixis.
- Active
- Registry status
- Phase 3
- Development phase
- 575
- Enrollment target
- 20
- Study locations
NCT04446117: Active Phase 3 study of Prostate Adenocarcinoma and Metastatic Prostate Cancer, sponsored by Exelixis.
NCT04446117 is a Phase 3 study of Prostate Adenocarcinoma and Metastatic Prostate Cancer that is active but no longer recruiting, run by Exelixis. The registered enrollment target is 575 participants, above the 213-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (170% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04446117, a Phase 3 study of Prostate Adenocarcinoma and Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Exelixis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 575 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.
Primary Outcome
Duration of PFS was defined as the time from randomization to the earlier of either the date of radiographic progression (defined as progressive disease \[PD\] per RECIST 1.1) per BIRC or the date of death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions, with an absolute increase of ≥ 5 mm, unequivocal progression of non-target lesions and/or the appearance of new lesions.
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Prednisone
- DRUG Cabozantinib
- DRUG Enzalutamide
- DRUG Abiraterone Acetate
Study Locations (20)
California
- Exelixis Clinical Site #42 - Duarte
- Exelixis Clinical Site #2 - Fullerton
- Exelixis Clinical Site #224 - La Jolla
- Exelixis Clinical Site #3 - Marina del Rey
- Exelixis Clinical Site #114 - San Diego
- Exelixis Clinical Site #125 - Santa Monica
- Exelixis Clinical Site #245 - Stanford
Colorado
- Exelixis Clinical Site #91 - Aurora
- Exelixis Clinical Site #14 - Denver
Connecticut
- Yale University School of Medicine - New Haven
- Yale University, School of Medicine - New Haven
Arizona
- Exelixis Clinical Site #4 - Tucson
Florida
- Exelixis Clinical Site #108 - Miami
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Kansas
- Exelixis Clinical Site #215 - Westwood
Kentucky
- Exelixis Clinical Site #242 - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2026-10-16 |
| Phase | Phase 3 |
What the registry record for NCT04446117 still lists
NCT04446117 is an interventional study that assigns participants to a tested intervention. The registered 575 participants enrollment target is mid-sized for trials with a published cap, above the 213-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (170% higher).
The record links to 2 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT04446117 names 20 study sites across 12 states, led by California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04446117 about?
NCT04446117 is a clinical study titled "Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC". This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have prev...
What is the current status of trial NCT04446117?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2020-10-19. Estimated completion is 2026-10-16.
What conditions does trial NCT04446117 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma, Metastatic Prostate Cancer.
What interventions are being tested in trial NCT04446117?
The interventions under investigation include: Atezolizumab (DRUG), Prednisone (DRUG), Cabozantinib (DRUG), Enzalutamide (DRUG), Abiraterone Acetate (DRUG).
Who is sponsoring clinical trial NCT04446117?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04446117 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04446117's enrollment target sits among peer trials
575 10th of 99 higher than 90 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma 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
-
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
RECRUITING · Phase 3
-
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
RECRUITING · Phase 3
-
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
RECRUITING · Phase 3
-
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
RECRUITING · Phase 3
-
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
RECRUITING · Phase 3
-
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02610439 · 575 participants
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
- NCT05919264 · 575 participants · Phase 1
FOG-001 in Locally Advanced or Metastatic Solid Tumors
- NCT06583148 · 575 participants · NA
A Smoke-Free Home Intervention in Tribal Communities
- NCT06883175 · 575 participants · NA
Evolution of the Chicago Classification: Bridging Physiology and Mechanics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI