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

Dendreon98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hormone-Refractory Prostate Cancer

Interventions

sipuleucel-TBIOLOGICAL

APC-PlaceboBIOLOGICAL

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Time to Disease Progression

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.

Time frame: from randomization to 36 months

Secondary Outcomes

Overall Survival

Subjects were followed for 3 years from the time of randomization or until death.

Time frame: Time from randomization until 36 months

Data from ClinicalTrials.gov

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