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Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT01338012
Recruitment Status : Terminated (Administrative reasons.)
First Posted : April 19, 2011
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Dendreon

Study Description
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Brief Summary:
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

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

Detailed Description:

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.

Study Objectives:

Primary: Evaluate the immune response generated by sipuleucel-T.

Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)
Study Start Date : December 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: sipuleucel-T
Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three 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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Study Participants Enrolled and Treated Prior to Study Termination [ Time Frame: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 ]
    Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.


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

Inclusion Criteria:

  • Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
  • Radiologic evidence of metastasis
  • Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
  • Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
  • Adequate hematologic function

Exclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status > 2
  • Treatment with chemotherapy within 3 months prior to registration
  • Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
  • Treatment with commercial sipuleucel-T (Provenge®)
  • Current or imminent pathologic long-bone fracture or spinal cord compression
  • Known malignancies other than prostate cancer likely to require treatment within 6 months following 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 GM-CSF
  • Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
  • Any surgery requiring general anesthetic within 28 days prior to registration
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01338012


Locations
United States, California
Orange County Urology Associates
Laguna Hills, California, United States, 92653
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Washington
Virginia Mason Hospital
Seattle, Washington, United States, 98101
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Dendreon
Investigators
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
More Information
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Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01338012     History of Changes
Other Study ID Numbers: P10-1
First Posted: April 19, 2011    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dendreon:
metastatic castrate resistant prostate cancer
prostate cancer
prostate
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
 cancer vaccine
prostatic adenocarcinoma
Sipuleucel-T
castration resistant prostate cancer (CRPC)
booster
retreatment
immune memory
immune response

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