N/A
Completed N=1,976
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
Advanced Prostate Cancer · Prostate Cancer
Source: ClinicalTrials.gov NCT01306890 ↗
Enrolled (actual)
1,976
Serious AEs
13.7%
Results posted
Jun 2019
Primary outcomePrimary: To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects — 1.2 events per 100 patient years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects |
1.2 | — |
| SECONDARY Survival |
30.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT01306890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.