A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
Public ClinicalTrials.gov record NCT03016312. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.
Study identification
- NCT ID
- NCT03016312
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 759 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 10, 2017 (Actual)
- Primary completion
- Jun 24, 2019 (Actual)
- Completion
- Dec 20, 2022 (Actual)
- Last update posted
- Aug 9, 2024
2017 – 2022
United States locations
- U.S. sites
- 39
- U.S. states
- 19
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Medical Grp Inc. | Duarte | California | 91010 | — |
| University of California San Diego | La Jolla | California | 92037-1337 | — |
| Kaiser Permanente San Diego - Los Angeles | Los Angeles | California | 90027 | — |
| UC Irvine Medical Center | Orange | California | 92868 | — |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | — |
| University of Colorado; Division of Medical Oncology | Aurora | Colorado | 80021 | — |
| Yale School of Medicine | New Haven | Connecticut | 06510-3206 | — |
| Stamford Hospital; BCC, MOHR | Stamford | Connecticut | 06904 | — |
| Lynn Cancer Institute/Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | — |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33916 | — |
| Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | 33176 | — |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | — |
| Investigative Clin Rsch of IN | Indianapolis | Indiana | 46260 | — |
| Associates in Oncology/Hematology P.C. | Rockville | Maryland | 20850 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | — |
| Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska | 68130 | — |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | — |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12208 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45230 | — |
| James Cancer Hospital;Solove Research Institute | Columbus | Ohio | 43210 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | — |
| University of Pittsburgh Cancer Institute; Division of Medical Oncology | Pittsburgh | Pennsylvania | 15232 | — |
| Miriam Hospital | Providence | Rhode Island | 02906 | — |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Sarah Cannon Research Institute / Tennessee Oncology | Chattanooga | Tennessee | 37404 | — |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | — |
| Texas Oncology - Methodist Dallas Cancer Center | Dallas | Texas | 75203 | — |
| Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology - Memorial City | Houston | Texas | 77024 | — |
| Texas Oncology-Tyler | Irving | Texas | 75063 | — |
| Virginia Cancer Specialists - Alexandria | Alexandria | Virginia | 22304 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03016312, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 9, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03016312 live on ClinicalTrials.gov.