for males ages 18 years and up (full criteria)
at Orange, California and other locations
study started
completion around



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.

Official Title

A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy


Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate, Prostatic Neoplasms, Leuprolide, Enzalutamide, Leuprolide Open Label, Enzalutamide plus leuprolide, Enzalutamide monotherapy


You can join if…

Open to males ages 18 years and up

  • 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).

You CAN'T join if...

  • 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


  • University of California, Irvine Medical Center
    Orange California 92868 United States
  • Tower Hematology Oncology Medical Group
    Beverly Hills California 90211 United States
  • Cedars-Senai OCC Pharmacy
    Los Angeles California 90048 United States
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    Los Angeles California 90048 United States


in progress, not accepting new patients
Start Date
Completion Date
Phase 3 Prostate Cancer Research Study
Study Type
About 1068 people participating
Last Updated