Clinical Trials in Canada / NCT02319837
Active, not recruiting
Phase 3
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)
NCT02319837 · tracked via the Priya Life Science Canada tracker
Condition(s) studied
Hormone Sensitive Prostate CancerProstate CancerCancer of the Prostate
Investigational drug(s) / intervention(s)
Placebo (No longer applicable in Open Label study period): Sugar pill to mimic enzalutamide
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.
Eligibility
Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
* Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
* PSA doubling time ≤ 9 months;
* Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer;
* Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).
Exclusion Criteria:
* Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
* Prior hormonal therapy. Neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization, or a single dose or a short course (≤ 6 months) of hormonal therapy given for rising PSA ≥ 9 months before randomization is allowed.;
* Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
* Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
* Major surgery within 4 weeks before randomization;
* Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
* Known or suspected brain metastasis or active leptomeningeal disease;
* History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
Primary outcome measure(s)
- Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide — From randomization until radiographic progression or death without radiographic progression, whichever occurred first (up to Month 98 when at least 197 MFS events occurred among the 3 treatment groups)
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 regions of the skeleton, including skull, thorax, spine, pelvis, and extremities). Confirmation with a second imaging modality (plain film, computed tomography \[CT\], or magnetic resonance imaging \[MRI\]) was to be required when bone lesions were found in a single region on the bone scan. Appearance of metastatic lesions in 2 or more of the 5 regions on a bone scan was not to require confirmation with a second imaging modality.
Trial sites (255)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| University of Alabama at Birmingham | Birmingham | Alabama | |
| University of Alabama at Birmingham, IDS Pharmacy | Birmingham | Alabama | |
| Alaska Urological Institute dba Alaska Clinical Research Center | Anchorage | Alaska | |
| Arizona Urology Specialists | Tucson | Arizona | |
| Tower Hematology Oncology Medical Group | Beverly Hills | California | |
| Cedars-Senai OCC Pharmacy | Los Angeles | California | |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | |
| University of California, Irvine Medical Center | Orange | California | |
| Sutter Medical Group, Vascular & Varicose Vein Center | Roseville | California | |
| Sutter Medical Group | Roseville | California | |
| UC Davis Comprehensive Cancer Center | Sacramento | California | |
| University of California Davis Medical Center | Sacramento | California | |
| University of California, Davis, School of Medicine | Sacramento | California | |
| The Urology Center of Colorado | Denver | Colorado | |
| Foothills Urology, P.C. | Golden | Colorado | |
| Eastern Connecticut Hematology Oncology Associates | Norwich | Connecticut | |
| Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | |
| Emory University Hospital | Atlanta | Georgia | |
| Northwestern Medical Group | Chicago | Illinois | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| First Urology, PSC | Jeffersonville | Indiana | |
| The University of Kansas Hospital | Kansas City | Kansas | |
| Kansas City Urology Care, PA | Overland Park | Kansas | |
| The University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | |
| GU Research Network/Wichita Urology Group | Wichita | Kansas | |
| John Hopkins University Hospital | Baltimore | Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | |
| The Sidney Kimmel Cancer Center at Johns Hopkins Hospital- Oncology Investigational Drug Services | Baltimore | Maryland | |
| Chesapeake Urology Research Associates | Towson | Maryland | |
| Comprehensive Urology - Macomb Office | Macomb | Michigan | |
| Comprehensive Urology - Royal Oak (Stephenson) office | Royal Oak | Michigan | |
| GU Research Network, LLC / Urology Cancer Center | Omaha | Nebraska | |
| VA Lahontan Valley Outpatient Clinic | Fallon | Nevada | |
| Memorial Sloan Kettering Cancer Center Basking Ridge | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Cancer Center Commack | Commack | New York | |
| Memorial Sloan Kettering Cancer Center Westchester | East White Plains | New York | |
| Memorial Hospital | New York | New York |
+ 215 more sites — see the full list on the official registry below.
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02319837 on ClinicalTrials.gov ↗ ← All trials in Canada