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

Information source: Medivation, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hormone Sensitive Prostate Cancer; Prostate Cancer; Cancer of the Prostate

Intervention: Enzalutamide (Drug); Placebo (Drug); Leuprolide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Medivation, Inc.

Overall contact:
William Novotny, MD, Phone: +1 (415) 983-3066, Email: William.Novotny@Medivation.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Metastasis-free survival (MFS)

Secondary outcome:

Overall survival

Proportion of patients per group who remain treatment-free 2 years after suspension of study drug treatment at week 37 due to undetectable Prostate-Specific Antigen (PSA).

Time to castration resistance

Prostate cancer-specific survival

Time to first symptomatic skeletal event

Composite of safety

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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 ≥ 2. 0 ng/mL for patients who had radical prostatectomy as primary

treatment for prostate cancer or ≥ 5. 0 ng/mL and greater than or equal to the nadir + 2 ng/mL for patients who had radiotherapy 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 other than neoadjuvant/adjuvant therapy to treat prostate

cancer ≤ 36 months in duration and ≥ 9 months before randomization;

- 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 and Contacts

William Novotny, MD, Phone: +1 (415) 983-3066, Email: William.Novotny@Medivation.com

Birminham, Alabama 35233, United States; Recruiting

Anchorage, Alaska 99503, United States; Recruiting

Tucson, Arizona 85741, United States; Recruiting

Vancouver, British Columbia V5Z 1M9, Canada; Recruiting

Torrance, California 90505, United States; Recruiting

Denver, Colorado 80211, United States; Recruiting

Boise, Idaho 83702, United States; Recruiting

Jeffersonville, Indiana 47130, United States; Recruiting

Wichita, Kansas 67226, United States; Recruiting

Towson, Maryland 21204, United States; Recruiting

Omaha, Nebraska 68130, United States; Recruiting

Coffs Harbour, New South Wales 2450, Australia; Recruiting

Sydney, New South Wales 2086, Australia; Not yet recruiting

Wahroonga, New South Wales 2076, Australia; Recruiting

Waratah, New South Wales 2298, Australia; Recruiting

Poughkeepsie, New York 12601, United States; Recruiting

Greensboro, North Carolina 27403, United States; Recruiting

Middleburg Heights, Ohio 44130, United States; Recruiting

Springfield, Oregon 97477, United States; Recruiting

Lancaster, Pennsylvania 17604, United States; Recruiting

Philadelphia, Pennsylvania 19107, United States; Recruiting

Quebec City, Quebec G1R 2J6, Canada; Recruiting

Southport, Queensland 4215, Australia; Recruiting

Myrtle Beach, South Carolina 29572, United States; Recruiting

Nashville, Tennessee 37232, United States; Recruiting

Dallas, Texas 75231, United States; Recruiting

San Antonio, Texas 78229, United States; Recruiting

Malvern, Victoria 3144, Australia; Recruiting

St. Albans, Victoria 3021, Australia; Recruiting

Virginia Beach, Virginia 23462, United States; Recruiting

Additional Information

Starting date: December 2014
Last updated: July 13, 2015

Page last updated: August 23, 2015

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