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Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (mCRPC)
This study has been terminated.
(Administrative reasons.)
Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01338012
First received: March 2, 2011
Last updated: June 1, 2017
Last verified: June 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Prostate Cancer | Biological: sipuleucel-T | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Sipuleucel-T
U.S. FDA Resources
Further study details as provided by Dendreon:
Primary Outcome Measures:
- 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.
| Enrollment: | 8 |
| Study Start Date: | December 2011 |
| Study Completion Date: | April 2015 |
| Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338012
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Dendreon |
| ClinicalTrials.gov Identifier: | NCT01338012 History of Changes |
| Other Study ID Numbers: |
P10-1 |
| Study First Received: | March 2, 2011 |
| Results First Received: | April 26, 2017 |
| Last Updated: | June 1, 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 |
ClinicalTrials.gov processed this record on September 25, 2017