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

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2003

Interventions

  • Biological: sipuleucel-T
  • Biological: APC-Placebo

Arms, Groups and Cohorts

  • Active Comparator: sipuleucel-T (APC8015)
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Overall Time to Disease Progression
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dendreon

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