Immune Monitoring on Sipuleucel-T
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/5/2017 |
| Start Date: | June 2012 |
| End Date: | December 2016 |
A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
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.
with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better
understand the mechanism of action of this treatment.
The primary objectives of this study are to:
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients unable to understand the research protocol and/or provide informed consent
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3
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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