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Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)

NCT02319837

Active Not RecruitingPhase 3

Sponsor: Pfizer

Conditions: Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate

Interventions: Enzalutamide, Placebo (No longer applicable in Open Label study period), Leuprolide Open Label

Countries: United States, Australia, Austria, Brazil, Canada, Denmark, Finland, France

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (255)

Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Anchorage, Alaska, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Roseville, California, United States
Roseville, California, United States
Sacramento, California, United States
Sacramento, California, United States
Sacramento, California, United States
Denver, Colorado, United States
Golden, Colorado, United States
Norwich, Connecticut, United States
Lakeland, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Jeffersonville, Indiana, United States
Kansas City, Kansas, United States
Overland Park, Kansas, United States
Westwood, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
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