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

Dendreon

Status and phase: Completed; Phase 3

Conditions: Hormone-Refractory Prostate Cancer

Treatments: Biological: APC-Placebo; Biological: sipuleucel-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT01133704

D9902A

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 2 patient groups, including a placebo group

sipuleucel-T (APC8015)

Active Comparator group

Treatment:

Biological: sipuleucel-T

Placebo

Placebo Comparator group

Treatment:

Biological: APC-Placebo