Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Castration Resistant Metastatic Prostate Cancer | Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Regulatory T cells (Tregs) | 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 | baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Antigen Presenting Cells | 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 | baseline and 1 year |
| Change in Prostate Antigen-specific T Cell Immunity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthew Galsky, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Nevada | Las Vegas | Nevada | 89169 | United States | ||
| Icahn School of Medicine at Mount Sinai |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood
| baseline and one year |
| Whole-blood RNA transcript-based signatures | whole-blood RNA transcript-based signatures correlate with overall survival | baseline |
| Whole-blood RNA transcript-based signatures | whole-blood RNA transcript-based signatures correlate with overall survival | up to 1 year |
| Change in cytokine milieu | baseline and 1 year |
| Change in chemokine milieu | baseline and 1 year |
| New York |
| New York |
| 10029 |
| United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |