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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 31, 2010
Last Update Posted: September 8, 2010
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.
Information provided by:
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 Intervention Phase
Hormone-Refractory Prostate Cancer Biological: sipuleucel-T Biological: APC-Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dendreon:

Primary Outcome 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 Outcome 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.

Enrollment: 98
Study Start Date: May 2000
Study Completion Date: May 2005
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sipuleucel-T (APC8015) Biological: sipuleucel-T
Placebo Comparator: Placebo Biological: APC-Placebo


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01133704     History of Changes
Other Study ID Numbers: D9902A
First Submitted: May 27, 2010
First Posted: May 31, 2010
Results First Submitted: June 1, 2010
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