Patients With Chemotherapy Naïve Metastatic 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: Age 18 years or older and willing and able to provide informed consent; Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features; Presence of metastatic disease as assessed by CT/MRI and/or whole body radionuclide bone scan; Throughout study, ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration); Testosterone = 1.73 nmol/L (= 50 ng/dL) at screening; Progressive disease on androgen deprivation therapy at screening defined as a minimum of 3 sequential rising PSA values (PSA1 =65 years) yes F.1.3.1 Number of subjects for this age range 420
Exclusion criteria
Exclusion criteria: 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); Medical contraindication to prednisone use; Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5 alpha reductase inhibitors) or biologic therapy for prostate cancer (other than denosumab, GnRH agonist/antagonist therapy, or corticosteroid therapy) within 4 weeks of screening; Use of an investigational agent within 4 weeks of the screening visit; Current or previously treated brain metastasis or active leptomeningeal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of combination treatment with continued enzalutamide plus abiraterone acetate (abiraterone) and prednisone (or prednisolone) compared with placebo plus abiraterone and prednisone as measured by progression free survival (PFS) after prostate-specific antigen (PSA) progression on treatment with enzalutamide in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (CRPC).;Secondary Objective: To evaluate the effect of combination treatment with continued enzalutamide plus abiraterone and prednisone compared with placebo plus abiraterone and prednisone after PSA progression on treatment with enzalutamide in patients with chemotherapy naïve metastatic CRPC on the following: Time to PSA progression, PSA response, objective response rate, rate of pain progression, time to first use of subsequent antineoplastic therapy for prostate cancer, quality of life and safety. Supplement 1 Study Objectives: To offer treatment access under Supplement 1 to all active and eligible patients for as long as there is clinical benefit as assessed by the treating physician based on clinical, laboratory and imaging data. To ensure continued safety monitoring to patients enrolled under Supplement 1, which will be conducted by local standard of care.;Primary end point(s): Progression Free Survival;Timepoint(s) of evaluation of this end point: PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression, unequivocal clinical progression, or death on study (death within 112 days of treatment discontinuation without objective evidence of radiographic progression), whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to PSA progression;Timepoint(s) of evaluation of this end point: Time to PSA progression is defined as the time from randomization to the date of the first PSA value demonstrating progression, which must be subsequently confirmed. | — |
Countries
Australia, Belgium, Denmark, Finland, France, Germany, Italy, Slovakia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed