NCT01338012

Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dendreon · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Detailed description

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases. During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone. Study Objectives: Primary: Evaluate the immune response generated by sipuleucel-T. Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sipuleucel-T	Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-04-19
• Last updated: 2017-06-05
• Results posted: 2017-06-05

Locations

4 sites across 1 country: United States