Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
completion around

Description

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.

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

Keywords

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

Eligibility

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

Locations

  • University of California, Irvine Medical Center
    Orange California 92868 United States
  • UC Davis Comprehensive Cancer Center
    Sacramento California 95817 United States
  • University of California Davis Medical Center
    Sacramento California 95817 United States
  • University of California, Davis, School of Medicine
    Sacramento California 95817 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT02319837
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
About 1068 people participating
Last Updated