Trials / Completed
CompletedNCT01306890
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,976 (actual)
- Sponsor
- Dendreon · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | sipuleucel-T | 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. |
Timeline
- Start date
- 2011-01-27
- Primary completion
- 2017-01-17
- Completion
- 2017-01-17
- First posted
- 2011-03-02
- Last updated
- 2019-06-07
- Results posted
- 2019-06-07
Locations
333 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01306890. Inclusion in this directory is not an endorsement.