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

• Status: Active, not recruiting
• Trial end date: 2026-09-19
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.; Pfizer
• Collaborators: Astellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
• Treatments: Leuprolide

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