EMBARK MDV3100-13

Study StatusEnrolling
ProtocolMDV3100-13
SponsorMedivation
Study Description

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; central randomization to one of three groups:
-Enzalutamide plus leuprolide
-Enzalutamide monotherapy
-Placebo plus leuprolide

Primary Endpoint

To evaluate efficacy, as measured by metastasis-free survival

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age
-Adenocarcinoma of the prostate
-Prostate cancer initially treated by RP or radiotherapy
-PSA doubling time ≤9 months as calculated by the sponsor
-Screening PSA ≥2.0 ng/ml for patients who had RP as primary treatment for prostate cancer or ≥5.0 ng/ml and greater than or equal to the nadir +2 ng/ml for patients who had RP as primary treatment for prostate cancer
-Serum testosterone ≥150 ng/dl
-ECOG 0 or 1 at screening and estimated life expectancy of ≥12 months
-Able to swallow the study drug and comply with study requirements including independently completing study questionnaires
-Patient and female partner of childbearing potential must use 2 acceptable methods of birth control and must use a condom if having sex with a pregnant woman; must agree not to donate sperm from first dose of study drug through 3 months after last dose of study drug

Exclusion Criteria

-Prior or present evidence of distant metastatic disease as assessed by CT, MRI, or chest x-ray for soft tissue disease and while-body radionuclide bone scan for bone disease. Patients with soft tissue pelvic disease may be eligible if lesions do not qualify as target lesions. If the screening bone scan shows a lesion suggestive of metastatic disease, the patient will be eligible only if a second imaging modality does not show bone metastasis. If the imaging results are equivocal or consistent with metastasis, the patient is not eligible for enrollment
-Prior hormonal therapy other than neoadjuvant/adjuvant therapy to treat prostate cancer ≤36 months in duration and ≥9 months before randomization
-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 date
-Treatment with a 5-a reductase inhibitor within 4 weeks of randomization
-For patients who had a prior prostatectomy, a suitable candidate for salvage radiotherapy as determined by the investigator in consideration of appropriate guidelines
-Participation in a clinical study of an investigational agent that inhibits the androgen receptor or androgen synthesis
-Use of any other investigational agent within 4 weeks before randomization date
-Known or suspected brain metastasis or active leptomeningeal disease or history of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of reoccurrence
-Absolute neutrophil count <1500/ul, platelet count <100,000/ul, or hemoglobin <10 g/dl, total bilirubin ≥2.5x upper limit of normal at screening, creatinine >2 mg/dl, albumin <3.0
-Hx of seizure or any condition that may predispose to seizure, hx of LOC or TIA within 12 months before randomization, MI within 6 months before screening, unstable angina within 3 months before screening, CHF, hx ventricular dysthymias, 2 or 3rd degree heart block, HTN SBP >170 or DBP >105 mm HG, GI disorder affecting absorption, any disease, infection or condition that interferes with the ability of the patient to participate in the study

Side Effects

Enzalutamide
-Weakness, back pain, decreased appetite, joint pain, diarrhea, hot flashes, upper respiratory tract infection, edema, headache, anxiety, dizziness, HTN, seizure, breast enlargement

Leuprolide
-Hot flashes, pain, joint pain, upset stomach, trouble urinating, weakness, depression, headache, change in breast size, edema, dizziness, muscle pain

Interested in enrolling in this trial? Please call 717-431-2285.


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