Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate

In brief

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Key facts

Study ID

NCT02003924

Run by

Pfizer

People needed

1401

Starts

2013-10-31

Expected to finish

2025-11-28

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
• Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
• Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
• Progressive disease on androgen deprivation therapy at enrollment;
• PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
• PSA doubling time ≤ 10 months;
• No prior or present evidence of metastatic disease;
• Asymptomatic prostate cancer;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Estimated life expectancy ≥ 12 months.

You may not qualify if…

• Prior cytotoxic chemotherapy;
• Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another invasive cancer within 3 years of randomization;
• Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
• Total bilirubin ≥ 1.5 times the upper limit of normal;
• Creatinine > 2 mg/dL (177 µmol/L) at screening;
• Albumin < 3.0 g/dL (30 g/L) at screening;
• History of seizure or any condition that may predispose to seizure;
• Clinically significant cardiovascular disease;
• Gastrointestinal disorder affecting absorption;
• Major surgery within 4 weeks of randomization;
• Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Clark Urology Center — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Urology Associates of San Luis Obispo, a Medical Group, Inc — San Luis Obispo, California, United States
• Urology Associates, P.C. — Englewood, Colorado, United States
• c/o Lynn Buchwalder — New Haven, Connecticut, United States
• C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven — New Haven, Connecticut, United States
• Smilow Cancer Center at Yale New Haven-Hospital — New Haven, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Urology of Indiana, LLC — Carmel, Indiana, United States
• First Urology, PSC — Jeffersonville, Indiana, United States
• IU Health Arnett Cancer Care — Lafayette, Indiana, United States
• Kansas City Urology Care, PA — Overland Park, Kansas, United States
• GU Research Network/ Wichita Urology Group — Wichita, Kansas, United States
• Chesapeake Urology Research Associates — Baltimore, Maryland, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• GU Research Network — Omaha, Nebraska, United States
• Brooklyn Urology Research Group — Brooklyn, New York, United States
• Premier Medical Group of the Hudson Valley — Newburgh, New York, United States
• Duke University Medical Center — Cary, North Carolina, United States
• Carolina Urology Partners, PLLC — Charlotte, North Carolina, United States
• Urological Associates of Southern Arizona, PC — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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