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

This study has been terminated.
(Administrative reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338012
First Posted: April 19, 2011
Last Update Posted: June 5, 2017
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.
Information provided by (Responsible Party):
Dendreon
March 2, 2011
April 19, 2011
April 26, 2017
June 5, 2017
June 5, 2017
December 2011
April 2015   (Final data collection date for primary outcome measure)
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.
To evaluate the immune response generated by sipuleucel-T [ Time Frame: From Baseline through Month 12 ]
Antigen-specific T cell responses will be assessed by mean of a proliferation assay and an interferon-gamma enzyme-linked immunospot (ELISPOT) assay. Antigen-specific humoral immune responses will be measured by means of an enzyme-linked immunosorbent assay (ELISA)
Complete list of historical versions of study NCT01338012 on ClinicalTrials.gov Archive Site
Not Provided
  • To evaluate the safety of sipuleucel-T [ Time Frame: Baseline to study completion ]
    Safety will be assessed by summarizing adverse events, laboratory evaluations, vital signs, and physical examination findings.
  • To explore the correlation between sipuleucel-T immune response and overall survival. [ Time Frame: Baseline to study completion ]
Not Provided
Not Provided
 
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
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)
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
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
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.
Intervention: Biological: sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01338012
P10-1
No
Not Provided
Plan to Share IPD: Undecided
Dendreon
Dendreon
Not Provided
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
Dendreon
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP