|Closed||Prostate Cancer||Phase III||NCT01212991|
The purpose of this study is to determine the benefit of MDV3100 versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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
- 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
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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