Immune Monitoring on Sipuleucel-T
PROVENGE
A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
1 other identifier
observational
36
1 country
3
Brief Summary
The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 9, 2014
CompletedFirst Posted
Study publicly available on registry
September 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 4, 2017
January 1, 2017
4.5 years
September 9, 2014
January 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Regulatory T cells (Tregs)
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
baseline and 1 year
Secondary Outcomes (6)
Change in Antigen Presenting Cells
baseline and 1 year
Change in Prostate Antigen-specific T Cell Immunity
baseline and one year
Whole-blood RNA transcript-based signatures
baseline
Whole-blood RNA transcript-based signatures
up to 1 year
Change in cytokine milieu
baseline and 1 year
- +1 more secondary outcomes
Study Arms (1)
Castration Resistant Metastatic Prostate Cancer
Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy
Eligibility Criteria
Patients will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site
You may qualify if:
- Age \> 18 years of age
- Written informed consent obtained
- Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy
- No prior systemic chemotherapy for metastatic prostate cancer
- Hemoglobin \> 9 mg/dl
You may not qualify if:
- Patients unable to understand the research protocol and/or provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, 89169, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Biospecimen
whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Galsky, MD
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2014
First Posted
September 11, 2014
Study Start
June 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 4, 2017
Record last verified: 2017-01