Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
With
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Randomized, Double Blind Treatment Period:
Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
No prior treatment with cytotoxic chemotherapy
Asymptomatic or mildly symptomatic from prostate cancer
Received randomized double-blind treatment in PREVAIL;
Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;
You may not be if
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
Known or suspected brain metastasis or active leptomeningeal disease
History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
Open-Label Treatment Period:
Has taken commercially available enzalutamide (Xtandi);
Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
Known or suspected brain metastasis or active leptomeningeal disease
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