Immune Monitoring on Sipuleucel-T (PROVENGE)

Mount Sinai Health System

Status: Completed

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02237170

GCO 11-1689

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

36 participants in 1 patient group

Castration Resistant Metastatic Prostate Cancer

Description:

Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy