Castrate Resistant Prostate Cancer, Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUGsipuleucel-T
DRUGipilimumab
Sponsors
Prostate Oncology Specialists, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antigen-specific memory T cell response | After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months | To quantify antigen-specific memory T cell response to sipuleucel-T and ipilimumab in combination. |
| Antigen-specific T cell proliferation to PA2024, PAP and PHA | After last sipuleucel-T and last ipilimumab, and follow-up period, an expected average of 15 months | 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 |
| Antibody responses against PA2024 and PAP | After last sipuleucel-T and last ipilimumab, and the follow-up period, an expected average of 15 months | To quantify antibody responses against PA2024 and PAP. * PA2024 is a recombinant protein * PAP: Prostatic acid phosphatase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to salvage therapy | Duration of the study, an expected average of 18 months | To quantify time to salvage therapy after treatment with sipuleucel-T and ipilimumab |
| Percentage PSA decline | Duration of the study, an expected average of 18 months | To measure percentage PSA decline following treatment with sipuleucel-T and ipilimumab |
| Prostate-Specific Antigen (PSA) doubling time | Duration of the study, an expected average of 18 months | To measure changes in PSA doubling time following treatment with sipuleucel-T and ipilimumab |
| Time to PSA progression | Duration of the study, an expected average of 18 months | To quantify time to PSA progression after treatment with sipuleucel-T and ipilimumab |
Countries
United States
Outcome results
None listed