Study on the Safety and Effectiveness of Enzalutamide Plus Leuprolide for Nonmetastatic Prostate Cancer (EMBARK)
Sponsor: Pfizer
ClinicalTrials ID:NCT02319837
This clinical trial is evaluating the combination of enzalutamide and leuprolide in patients with high-risk prostate cancer that has not spread to other parts of the body and is progressing after surgery or radiation therapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to determine how safe and effective the combination of enzalutamide and leuprolide is for treating patients with high-risk prostate cancer that has not spread beyond the prostate and is getting worse after surgery or radiation therapy. The study initially involved a randomized and blinded phase, which has now been completed. It is currently ongoing in an open-label format, meaning all participants know which treatment they are receiving.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of prostate cancer without certain rare cell types.
- Previously treated with surgery or radiation therapy, or both, with the goal of curing the cancer.
- PSA (a marker of prostate cancer activity) doubling time of 9 months or less.
- PSA level of at least 1 ng/mL for those who had surgery, or at least 2 ng/mL above the lowest level for those who had only radiation therapy.
- Testosterone level of at least 150 ng/dL.
Exclusion Criteria
- Evidence of cancer spreading to distant parts of the body.
- Previous hormonal therapy, except for specific conditions related to timing and duration.
- Previous chemotherapy or certain medications for prostate cancer.
- Previous systemic biological or immune therapy for prostate cancer.
- Major surgery within 4 weeks before starting the study.
- Recent use of certain medications for prostate conditions.
- Known or suspected cancer spread to the brain or spinal fluid.
- History of another invasive cancer within the last 3 years, except for fully treated cancers with low risk of coming back.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham | 35233 | Birmingham | Alabama |
| University of Alabama at Birmingham, IDS Pharmacy | 35249 | Birmingham | Alabama |
| University of Alabama at Birmingham | 35249 | Birmingham | Alabama |
| Alaska Urological Institute dba Alaska Clinical Research Center | 99503 | Anchorage | Alaska |
| Urological Associates of Southern Arizona, PC | 85741 | Tucson | Arizona |
| Tower Hematology Oncology Medical Group | 90211 | Beverly Hills | California |
| Cedars-Senai OCC Pharmacy | 90048 | Los Angeles | California |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | 90048 | Los Angeles | California |
| University of California, Irvine Medical Center | 92868 | Orange | California |
| Sutter Medical Group, Vascular & Varicose Vein Center | 95661 | Roseville | California |
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