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

This study has been completed.
Sponsor:
Information provided by:
Dendreon
ClinicalTrials.gov Identifier:
NCT01133704
First received: May 27, 2010
Last updated: September 2, 2010
Last verified: September 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Overall Time to Disease Progression [ Time Frame: from randomization to 36 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

No publications provided

ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 19, 2013