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.
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
Drug | Synonyms | Arms |
---|
Enzalutamide | MDV3100, Xtandi | Enzalutamide monotherapy |
Placebo | | Placebo plus leuprolide |
Leuprolide | Eligard, Leuprolide Acetate, Leuprorelin, Lupron | Enzalutamide 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
Name | Type | Description | Interventions |
---|
Enzalutamide plus leuprolide | Experimental | Enzalutamide (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 monotherapy | Experimental | Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily | |
Placebo plus leuprolide | Active Comparator | Enzalutamide 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 | |
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: | Up to approximatey 67 months |
Safety Issue: | |
Description: | Compared between enzalutamide plus leuprolide and placebo plus leuprolide. |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | Up to approximately 96 months |
Safety Issue: | |
Description: | |
Measure: | Time to castration resistance |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Composite of safety |
Time Frame: | Up to approximately 67 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. |
Measure: | Metastasis-free survival (MFS) |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | Compared between enzalutamide monotherapy versus placebo plus leuprolide. |
Measure: | Time to prostate specific antigen (PSA) progression; |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Time to first use of new antineoplastic therapy |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Time to distant metastasis |
Time Frame: | Up to approximately 67 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 PSA |
Time Frame: | From baseline (week 37) up to 67 months |
Safety Issue: | |
Description: | |
Measure: | Proportion of patients per group with undetectable PSA 2 years after suspension of study drug treatment at week 37 due to undetectable PSA |
Time Frame: | From baseline (week 37) up to 67 months |
Safety Issue: | |
Description: | |
Measure: | Proportion of patients per group with undetectable PSA at 36 weeks on study drug |
Time Frame: | At week 36 |
Safety Issue: | |
Description: | |
Measure: | Time to resumption of any hormonal therapy following suspension at week 37 due to undetectable PSA |
Time Frame: | From baseline (week 37) up to 67 months |
Safety Issue: | |
Description: | |
Measure: | Time to symptomatic progression |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Time to first symptomatic skeletal event |
Time Frame: | Up to approximately 96 months |
Safety Issue: | |
Description: | |
Measure: | Time to clinically relevant pain |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Quality of life via the Functional Assessment of Cancer Therapy Prostate (FACT P) questionnaire, |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Quality of life via the European Quality of Life 5 Dimensions 5 Levels Health Questionnaire (EQ 5D 5L), |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Measure: | Quality of life via the Quality of Life Questionnaire Prostate 25 (QLQ PR25) module |
Time Frame: | Up to approximately 67 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Pfizer |
Last Updated
August 19, 2021