Skip to main content
OpenTrials
Completed

NCT Number: NCT02237170

Immune Monitoring on 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Comprehensive Cancer Center of Nevada, Las Vegas, Nevada, United States

Loading trial locations.

About this study

The primary objectives of this study are to:

  • Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T.
  • Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T.
  • Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T.
  • Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in Regulatory T cells (Tregs)

    Time frame: baseline and 1 year

    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

Secondary outcomes

  1. Change in Antigen Presenting Cells

    Time frame: baseline and 1 year

    Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in antigen presenting cells: DCs and B cells at 1 year post treatment compared to at baseline

  2. Change in Prostate Antigen-specific T Cell Immunity

    Time frame: baseline and one year

  3. Whole-blood RNA transcript-based signatures

    Time frame: baseline

    whole-blood RNA transcript-based signatures correlate with overall survival

  4. Whole-blood RNA transcript-based signatures

    Time frame: up to 1 year

    whole-blood RNA transcript-based signatures correlate with overall survival

  5. Change in cytokine milieu

    Time frame: baseline and 1 year

  6. Change in chemokine milieu

    Time frame: baseline and 1 year

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T

Acronym: PROVENGE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 11, 2014
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.