Open Label Study of Sipuleucel-T in Metastatic 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: NCT00901342
Recruitment Status : Completed
First Posted : May 13, 2009
Results First Posted : April 12, 2017
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):

Brief Summary:
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: sipuleucel-T Phase 2

Detailed Description:
Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Study Start Date : October 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Sipuleucel-T
Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
Other Name: • Provenge® • APC8015

Primary Outcome Measures :
  1. Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC) [ Time Frame: Day 0 (first infusion) and up to 3 infusions at 2-week intervals ]

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

Inclusion Criteria:

  • Histologically documented adenocarcinoma of the prostate
  • Metastatic disease
  • Castrate resistant prostate cancer
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
  • Life expectancy of ≥ 3 months
  • Men ≥ 18 years of age
  • Adequate hematologic, renal and liver function

Exclusion Criteria:

  • Presence of known lung, liver, or brain metastases
  • Evidence of neuroendocrine or small cell features
  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
  • Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
  • Known malignancies other than prostate cancer that are likely to require treatment within six months of registration
  • A requirement for systemic immunosuppressive therapy for any reason
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or granulocyte-macrophage colony-stimulating factor
  • Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within 1 week prior to registration
  • Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives

Treatment with any of the following medications or interventions within 28 days of registration:

  • Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
  • Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide)
  • External beam radiation therapy or major surgery requiring general anesthetic
  • Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary
  • Chemotherapy
  • Treatment with any other investigational product

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901342

United States, District of Columbia
Georgetown University Medical Center
Washington, D.C., District of Columbia, United States, 20007
United States, Illinois
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Oncology Specialists, S.C.
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana University Department of Urology
Indianapolis, Indiana, United States, 46202
United States, Maine
Maine Center for Cancer Medicine
Scarborough, Maine, United States, 04074
United States, Maryland
Hematology Oncology Consultants
Greenbelt, Maryland, United States, 20770
Myron I. Murdock MD LLC
Greenbelt, Maryland, United States, 20770
United States, New Jersey
John Theurer Cancer Center at Hackensack
Hackensack, New Jersey, United States, 07601
United States, New York
NYU Cancer Institute
New York, New York, United States, 10016
Mount Sinai School of Medicine Department of Urology
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
GU Oncology Research Program
Durham, North Carolina, United States, 27710
United States, Ohio
Oncology Hematology Care, Inc.
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, PA - Sammons Cancer Center
Dallas, Texas, United States, 75246
United States, Virginia
Urology of Virginia, PLLC
Virginia Beach, Virginia, United States, 23642
United States, Washington
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, United States, 98101
United States, Wisconsin
Aurora Advanced Healthcare, Inc
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC

Additional Information:
Responsible Party: Dendreon Identifier: NCT00901342     History of Changes
Other Study ID Numbers: P09-1
First Posted: May 13, 2009    Key Record Dates
Results First Posted: April 12, 2017
Last Update Posted: May 23, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dendreon:
Androgen independent prostate cancer (AIPC)
prostate cancer
immune therapy
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
prostate specific antigen (PSA)
prostatic adenocarcinoma

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases