A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Dendreon1,976 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,976

Conditions

Advanced Prostate Cancer Prostatic Neoplasms

Interventions

sipuleucel-TBIOLOGICAL

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (333)

Outcomes

Primary Outcomes

To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects

The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.

Time frame: Every 3 months for a minimum of 3 years

Secondary Outcomes

Survival

To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.

Time frame: Every 3 months for a minimum of 3 years

Data from ClinicalTrials.gov

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