Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
1 other identifier
interventional
104
1 country
18
Brief Summary
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Oct 2009
Typical duration for phase_2 prostate-cancer
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
April 12, 2017
CompletedMay 23, 2017
April 1, 2017
5.2 years
May 7, 2009
March 1, 2017
April 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Study Arms (1)
Sipuleucel-T
EXPERIMENTALSubjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of known lung, liver, or brain metastases
- Evidence of neuroendocrine or small cell features
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- 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
- Chemotherapy
- Treatment with any other investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (18)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
The University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Indiana University Department of Urology
Indianapolis, Indiana, 46202, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04074, United States
Hematology Oncology Consultants
Greenbelt, Maryland, 20770, United States
Myron I. Murdock MD LLC
Greenbelt, Maryland, 20770, United States
John Theurer Cancer Center at Hackensack
Hackensack, New Jersey, 07601, United States
NYU Cancer Institute
New York, New York, 10016, United States
Mount Sinai School of Medicine Department of Urology
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
GU Oncology Research Program
Durham, North Carolina, 27710, United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology, PA - Sammons Cancer Center
Dallas, Texas, 75246, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23642, United States
Virginia Mason Medical Center Urology and Renal Transplantation
Seattle, Washington, 98101, United States
Aurora Advanced Healthcare, Inc
Wauwatosa, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shabnam Vaziri
- Organization
- Dendreon
Study Officials
- STUDY DIRECTOR
Robert Israel, MD
Valeant Pharmaceuticals North America LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2009
First Posted
May 13, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2014
Study Completion
June 1, 2015
Last Updated
May 23, 2017
Results First Posted
April 12, 2017
Record last verified: 2017-04