Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2012-06-30
2016-12-31
Brief Summary
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Detailed Description
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1. Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
2. Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
3. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
4. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Castration Resistant Metastatic Prostate Cancer
Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Principal Investigators
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Matthew Galsky, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Countries
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Other Identifiers
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GCO 11-1689
Identifier Type: -
Identifier Source: org_study_id
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