A Multinational, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer - MDV3100-14 Prosper

Medivation Inc., a wholly owned subsidiary of Pfizer Inc.0 个研究点目标入组 42 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•Each patient eligible to participate in this study must meet all of the
•following criteria: (the full list of inclusion criteria can be found on page
•21 of the protocol)
•1. Age 18 years or older and willing and able to provide informed consent;
•2. Histologically or cytologically confirmed adenocarcinoma of the prostate
•without neuroendocrine differentiation, signet cell, or small cell features;
•3. Ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior
•bilateral orchiectomy (medical or surgical castration);
•4. Testosterone <= 50 ng/dL (<= 1.73 nmol/L) at screening;
•5. For patients receiving bisphosphonates or denosumab, dose must be stable for
•at least 4 weeks before randomization;
•6. Progressive disease on androgen deprivation therapy at enrollment defined as
•a minimum of 3 rising PSA values (PSA1 < PSA2 < PSA3) assessed by a local
•laboratory (local PSA) with an interval of >= 1 week between each determination;

•Each patient eligible to participate in this study must NOT meet any of the
•following exclusion criteria: (the full list of exclusion criteria can be found
•on page 22 of the protocol)
•1. Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone
•acetate, or enzalutamide for the treatment of prostate cancer or participation
•in a clinical trial of an investigational agent that inhibits the androgen
•receptor or androgen synthesis (unless treatment was placebo);
•2. Treatment with hormonal therapy (eg, androgen receptor inhibitors,
•estrogens, 5-alpha reductase inhibitors) or biologic therapy for prostate
•cancer (other than approved bone-targeting agents and GnRH agonist/antagonist
•therapy) within 4 weeks of randomization;
•3. Use of an investigational agent within 4 weeks of randomization;
•4. Known or suspected brain metastasis or active leptomeningeal disease;
•5. History of another invasive cancer within 3 years of randomization, with the
•exception of fully treated cancers with a remote probability of recurrence in
•the opinion of both the medical monitor and investigator;

发起方

Medivation Inc., a wholly owned subsidiary of Pfizer Inc.