Prostate Cancer Clinical Trial
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Summary
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
Full Description
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
Eligibility Criteria
Inclusion Criteria:
subjects must be at least 18 years of age
subjects with advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T ≤ 6 months prior to enrollment
subjects must understand and sign an informed consent form
Exclusion Criteria:
none
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