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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sipuleucel-T
Sponsored by
Dendreon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Orange County Urology Associates
  • Oregon Health & Science University
  • Virginia Mason Hospital
  • Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sipuleucel-T

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Study Participants Enrolled and Treated Prior to Study Termination
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2011
Last Updated
June 1, 2017
Sponsor
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT01338012
Brief Title
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
Acronym
mCRPC
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 Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons.
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dendreon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sipuleucel-T
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
sipuleucel-T
Other Intervention Name(s)
PROVENGE, APC8015
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Study Participants Enrolled and Treated Prior to Study Termination
Description
Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Time Frame
Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Israel, MD
Organizational Affiliation
Valeant Pharmaceuticals North America LLC
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Urology Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Virginia Mason Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

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