Patients With Nonmetastatic Castration Resistant Prostate Cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 1170
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of enzalutamide compared with placebo as assessed by metastasis free survival (MFS).;Secondary Objective: * To evaluate the benefit of enzalutamide compared with placebo as measured by the following: - Time to PSA progression - Time to first use of new antineoplastic therapy - Overall survival - Time to pain progression - Time to first use of cytotoxic chemotherapy - Chemotherapy-free disease-specific survival - Chemotherapy-free survival - PSA response rates - Quality of life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire, European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) health questionnaire, and Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) module * To evaluate safety;Primary end point(s): Metastasis free survival (MFS), assessed by blinded independent central radiology review;Timepoint(s) of evaluation of this end point: MFS is defined as the time from randomization to radiographic progression or death on study (death within 112 days of treatment discontinuation without evidence of radiographic progression), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: - Time to PSA Progression - Time to First Use of New Antineoplastic Therapy - Overall Survival Additional secondary endpoints are as follows: - Time to Pain Progression - Time to First Use of Cytotoxic Chemotherapy - Chemotherapy-Free Disease-Specific Survival - Chemotherapy-Free Survival - PSA Response - Quality of Life as Assessed by the FACT-P questionnaire, EQ-5D-5L Health Questionnaire, and QLQ-PR25 Module;Timepoint(s) of evaluation of this end point: The single MFS analysis will be performed after approximately 440 MFS events occur. All secondary endpoints will be evaluated for efficacy at this time. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed