Home
Clinical Trials
Safety and Efficacy Study of ...

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

NCT ID: NCT02003924

Last Updated: 2025-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1401 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

NCT02124668

Castration-Resistant Prostate Cancer Prostate Cancer

COMPLETED PHASE2

A Study to Test if Enzalutamide is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

NCT01302041

Prostate Cancer

COMPLETED PHASE2

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

NCT01212991

Prostate Cancer

COMPLETED PHASE3

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients

NCT01995513

Prostate Cancer

COMPLETED PHASE4

Genetic and Molecular Mechanisms in Assessing Response in Patients With Prostate Cancer Receiving Enzalutamide Therapy

NCT02099864

Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Soft Tissues +4 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nonmetastatic Castration-Resistant Prostate Cancer Prostate Cancer Cancer of the Prostate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill to mimic enzalutamide

Enzalutamide

160 mg by mouth once daily

Group Type EXPERIMENTAL

Enzalutamide

Intervention Type DRUG

160 mg by mouth once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enzalutamide

160 mg by mouth once daily

Intervention Type DRUG

Placebo

Sugar pill to mimic enzalutamide

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MDV3100 Xtandi

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Urological Associates of Southern Arizona, PC

Tucson, Arizona, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA Clark Urology Center

Los Angeles, California, United States

Site Status

University of California, Irvine Medical Center

Orange, California, United States

Site Status

Urology Associates of San Luis Obispo, a Medical Group, Inc

San Luis Obispo, California, United States

Site Status