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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01133704
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 8, 2010
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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.

Condition or disease Intervention/treatment Phase
Hormone-Refractory Prostate Cancer Biological: sipuleucel-T Biological: APC-Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : May 2000
Primary Completion Date : March 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: sipuleucel-T (APC8015) Biological: sipuleucel-T
Placebo Comparator: Placebo Biological: APC-Placebo

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Overall Survival [ Time Frame: Time from randomization until 36 months ]
    Subjects were followed for 3 years from the time of randomization or until death.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01133704     History of Changes
Other Study ID Numbers: D9902A
First Posted: May 31, 2010    Key Record Dates
Results First Posted: September 2, 2010
Last Update Posted: September 8, 2010
Last Verified: September 2010

Keywords provided by Dendreon:
asymptomatic metastatic hormone-refractory prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs