Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

Phase 3

Completed

• Conditions: Hormone-Refractory Prostate Cancer
• Interventions: Biological: APC-Placebo; Biological: sipuleucel-T

• Registration Number: NCT01133704
• Lead Sponsor: Dendreon

Brief Summary

This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2003-03
• Study Completion: 2005-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-05-28
• Study First Posted: 2010-05-31
• Results First Submitted: 2010-06-01
• Results First Submitted QC: 2010-08-17
• Status Verified: 2010-09
• Results First Posted: 2010-09-02
• Last Update Submitted: 2010-09-02
• Last Update Posted: 2010-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 98

Inclusion Criteria

• Histologically documented adenocarcinoma of the prostate
• Metastatic disease as evidenced by soft tissue and/or bony metastases
• Prostate-specific antigen value of at least 5 ng/mL
• Tumor progression while on hormonal therapy
• Castration levels of testosterone (defined as less than 50 ng/dL)
• Life expectancy of at least 16 weeks
• Adequate hematologic, renal, and liver function

Exclusion Criteria

• Visceral organ metastases
• Metastatic disease expected to be in need of radiation therapy within 4 months.
• Concurrent therapy with experimental agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	APC-Placebo	-
sipuleucel-T (APC8015)	sipuleucel-T	-

Primary Outcome Measures

Name	Time	Method
Overall Time to Disease Progression	from randomization to 36 months	Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Time from randomization until 36 months	Subjects were followed for 3 years from the time of randomization or until death.