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NCT02319837 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
A Phase 3 study of Prostate Cancer and Cancer of the Prostate, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 1,068
- Enrollment target
- 20
- Study locations
NCT02319837: Active Phase 3 study of Prostate Cancer and Cancer of the Prostate, sponsored by Pfizer.
NCT02319837 is a Phase 3 study of Prostate Cancer and Cancer of the Prostate that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 1,068 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (76% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02319837, a Phase 3 study of Prostate Cancer and Cancer of the Prostate, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,068 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study remains ongoing in open label format.
Primary Outcome
MFS was defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death without radiographic progression, whichever occurred first. Radiographic progression for soft tissue disease was defined by Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1). Radiographic progression for bone disease was defined as the appearance of 1 or more metastatic lesions on bone scan (a bone scan assesses 5
Conditions Studied
Interventions
- DRUG Enzalutamide
- DRUG Placebo (No longer applicable in Open Label study period)
- DRUG Leuprolide Open Label
Study Locations (20)
California
- Tower Hematology Oncology Medical Group - Beverly Hills
- Cedars-Senai OCC Pharmacy - Los Angeles
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute - Los Angeles
- University of California, Irvine Medical Center - Orange
- Sutter Medical Group, Vascular & Varicose Vein Center - Roseville
- Sutter Medical Group - Roseville
- UC Davis Comprehensive Cancer Center - Sacramento
- University of California Davis Medical Center - Sacramento
- University of California, Davis, School of Medicine - Sacramento
Alabama
- University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham, IDS Pharmacy - Birmingham
- University of Alabama at Birmingham - Birmingham
Colorado
- The Urology Center of Colorado - Denver
- Foothills Urology, P.C. - Golden
Georgia
- Emory University Hospital - Atlanta
- Winship Cancer Institute, Emory University - Atlanta
Alaska
- Alaska Urological Institute dba Alaska Clinical Research Center - Anchorage
Arizona
- Urological Associates of Southern Arizona, PC - Tucson
Connecticut
- Eastern Connecticut Hematology Oncology Associates - Norwich
Florida
- Lakeland Regional Health Hollis Cancer Center - Lakeland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,068 participants |
| Start Date | 2014-12-17 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 3 |
What the registry record for NCT02319837 still lists
NCT02319837 is an interventional study that assigns participants to a tested intervention. Its 1,068 participants enrollment target places it among the larger protocols in the corpus, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (76% higher).
The record links to 3 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enzalutamide is the first listed.
NCT02319837 names 20 study sites across 8 states, led by California, Alabama, Colorado.
Frequently Asked Questions
What is clinical trial NCT02319837 about?
NCT02319837 is a clinical study titled "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)". The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both. The randomized / blinded portion of the study is now completed following primary endpoint analyses. The study...
What is the current status of trial NCT02319837?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,068 participants. The study started on 2014-12-17. Estimated completion is 2026-09-19.
What conditions does trial NCT02319837 study?
This clinical trial studies the following conditions: Prostate Cancer, Cancer of the Prostate, Hormone Sensitive Prostate Cancer.
What interventions are being tested in trial NCT02319837?
The interventions under investigation include: Enzalutamide (DRUG), Placebo (No longer applicable in Open Label study period) (DRUG), Leuprolide Open Label (DRUG).
Who is sponsoring clinical trial NCT02319837?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02319837 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02319837's enrollment target sits among peer trials
1,068 50th of 735 higher than 686 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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