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

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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.

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.

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
We found this trial at
3
sites
1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Las Vegas, Nevada 89169
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New York, New York 10021
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