Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer - Full Text View

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: No masking 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

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
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 June 28, 2017

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