Clinical Trials /

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

NCT02319837

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: MDV3100-13
  • SECONDARY ID: C3431004
  • SECONDARY ID: 2014-001634-28
  • NCT ID: NCT02319837

Conditions

  • Hormone Sensitive Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate

Interventions

DrugSynonymsArms
EnzalutamideMDV3100, XtandiEnzalutamide plus leuprolide
PlaceboPlacebo plus leuprolide
LeuprolideEligard, Leuprolide Acetate, Leuprorelin, LupronEnzalutamide plus leuprolide

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Enzalutamide plus leuprolideExperimentalEnzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks
  • Enzalutamide
  • Leuprolide
Enzalutamide monotherapyExperimentalEnzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
  • Enzalutamide
Placebo plus leuprolideActive ComparatorEnzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks
  • Placebo
  • Leuprolide

Eligibility 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 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).

        Exclusion Criteria:

          -  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
      
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:During Study Period up to 56 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall survival
Time Frame:During Study Period up to 110 months
Safety Issue:
Description:
Measure: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 Frame:During Study Period up to 56 months
Safety Issue:
Description:
Measure:Time to castration resistance
Time Frame:During Study Period up to 56 months
Safety Issue:
Description:The time to castration resistance is defined as the time from randomization to the date of the first PSA increase while on study drug treatment that is >= 25% and >= 2 μg/L above the nadir or screening value, whichever is lower, and that is confirmed by a second consecutive value obtained at least 3 weeks later.
Measure:Prostate cancer-specific survival
Time Frame:During Study Period up to 110 months
Safety Issue:
Description:
Measure:Time to first symptomatic skeletal event
Time Frame:During Study Period up to 56 months
Safety Issue:
Description:
Measure:Composite of safety
Time Frame:During Study Period up to 56 months
Safety Issue:
Description:Safety will be evaluated by the incidence of serious adverse events, incidence and severity of adverse events, incidence of permanent treatment discontinuation due to adverse events, and incidence of new clinically significant changes in clinical laboratory values and vital signs.

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pfizer

Last Updated

February 12, 2018