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

This study has been completed.
Information provided by:
Dendreon Identifier:
First received: May 27, 2010
Last updated: September 2, 2010
Last verified: September 2010
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01133704     History of Changes
Other Study ID Numbers: D9902A
Study First Received: May 27, 2010
Results First Received: June 1, 2010
Last Updated: September 2, 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 processed this record on September 21, 2017