Clinical Trials /

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

NCT02003924

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title:Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
  • Official Title:A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: MDV3100-14
  • NCT ID: NCT02003924

Trial Conditions

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

Trial Interventions

DrugSynonymsArms
EnzalutamideMDV3100, XtandiEnzalutamide
PlaceboPlacebo

Trial Purpose

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

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
PlaceboSham ComparatorSugar pill manufactured to mimic enzalutamide 40 mg capsule
    • Placebo
EnzalutamideExperimental160 mg by mouth once daily
  • Enzalutamide

    Eligibility Criteria

    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.

    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Metastasis Free Survival (MFS)
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:

    Secondary Outcome Measures

    Measure:Overall Survival (OS)
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Time to Pain Progression
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Time to Opiate Use for Prostate Cancer Pain
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Time to First Use of Cytotoxic Chemotherapy
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Time to First Use of New Antineoplastic Therapy
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Time to Prostate-Specific Antigen (PSA) Progression
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:FACT-P Global Score
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:
    Measure:Quality of Life as assessed by EQ-5D-5L and QLQ-PR25
    Time Frame:≥ 16 weeks
    Safety Issue:No
    Description:

    Trial Keywords