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Sipuleucel-T With or Without Radiation Therapy in Castrate Resistant Metastatic Prostate Cancer
NCT01807065Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2013
- Primary completion
- Dec 2018
- Countries
- 1
- Sponsor
- City of Hope
- Modality
- Whole Cell Cancer Vaccines, Dendritic Cell Vaccines, Fc-Fusion Proteins
- Drugs
- sipuleucel-T
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, randomised, open-label trial of sipuleucel-T in prostate cancer (PCa) (2 arms), sponsored by City of Hope. Primary endpoint: Progression-Free Survival up to 2 years. Started Jun 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm A (sipuleucel-T)
Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.
Arm B (radiation therapy, sipuleucel-T)
Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.
03
Who it enrols
Men with castrate-resistant metastatic prostate cancer, ECOG <= 2, life expectancy >= 6 months, adequate organ function, and no recent chemotherapy or systemic corticosteroids.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Number of Participants With Grade 2 or Above Adverse Events
Immune Response to PAP and PA2024
Prostate Specific Antigen Response
Radiographic Response Rate
Time to Need for Subsequent Therapy
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