Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

Prostate Oncology Specialists, Inc.9 enrolled

Overview

This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Castrate Resistant Prostate Cancer

Interventions

sipuleucel-TDRUG

ipilimumabDRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T * Subjects must understand and sign an informed consent form Exclusion Criteria: * Subjects who are not eligible to receive sipuleucel-T

Locations (1)

Prostate Oncology Specialists, Inc.

Marina del Rey, California, United States

Outcomes

Primary Outcomes

Antigen-specific memory T cell response

To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination.

Time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months

Antigen-specific T cell proliferation to PA2024, PAP and PHA

To quantify Antigen-specific T cell proliferation to PA2024, PAP and PHA when sipuleucel-T and ipilimumab are given in combination. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase * PHA: Phytohaemagglutinin, an assay control

Time frame: After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months

Antibody responses against PA2024 and PAP

To quantify antibody responses against PA2024 and PAP. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase

Time frame: After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months

Secondary Outcomes

Prostate-Specific Antigen (PSA) doubling time

To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab

Time frame: Duration of the study, an expected average of 18 months

Time to PSA progression

To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab

Time frame: Duration of the study, an expected average of 18 months

Time to salvage therapy

To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab

Time frame: Duration of the study, an expected average of 18 months

Data from ClinicalTrials.gov

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