Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
18 Years
N/A
Male
Prostate Cancer
Trial Information
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Subjects will receive sipuleucel-T, and potentially other medications, as part of the
clinical trial in which they are concurrently enrolled. For this study, cellular and humoral
immune responses will be assessed. No additional study treatments will be conducted beyond
what is required for the subject's concurrent clinical trial.
Inclusion Criteria:
- Subjects must be at least 18 years of age
- Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T
(including a Dendreon-sponsored clinical trial or registry, or an IIT)
- Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
- Subjects must understand and sign an informed consent form prior to their first
leukapheresis
Exclusion Criteria:
•None
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
To evaluate the immune response following sipuleucel-T therapy for all subjects
Outcome Description:
To evaluate the immune response following sipuleucel-T therapy for all subjects
Outcome Time Frame:
up to 52 weeks
Safety Issue:
No
Principal Investigator
Candice McCoy, MD
Investigator Role:
Study Director
Investigator Affiliation:
Dendreon
Authority:
United States: Food and Drug Administration
Study ID:
P11-4
NCT ID:
NCT01727154
Start Date:
October 2012
Completion Date:
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada 89109 |
| Michigan Institute of Urology | Detroit, Michigan 48236 |
| Henry Ford Health System | Detroit, Michigan 48202 |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Karmanos Cancer Center | Detroit, Michigan 48201 |
| Tulane University | New Orleans, Louisiana 70112-2699 |
| Oregon Urology Institute | Springfield, Oregon 97477 |
| The Urology Center of Colorado | Denver, Colorado 80211 |
| St. Louis Cancer Care, LLP | Chesterfield, Missouri 63017 |
| 21st Century Oncology | Cape Coral, Florida 33990 |
| Prostate Oncology Specialists, Inc. | Marina Del Rey, California 90292 |
| Arizona Oncology Associates, PC - HOPE | Tucson, Arizona 85704 |
| Texas Oncology - Austin Midtown | Austin, Texas 78705 |
| Texas Oncology - Austin Central | Austin, Texas 78731 |
| Karmanos Cancer Institute at Farmington Hills | Farmington Hills, Michigan 48334 |
| Premier Medical Group of the Hudson Valley | Poughkeepsie, New York 12601 |
| Urology Cancer Center & GU Research Network | Omaha, Nebraska 68130 |
| Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina | Cary, North Carolina 27518 |
| Urology Associates, P.C. | Nashville, Tennessee 37209 |
| Texas Oncolocy - South Austin | Austin, Texas 78745 |
| Texas Oncology - Austin North | Austin, Texas 78758 |
| Texas Oncology - Cedar Park | Cedar Park, Texas 78613 |
| Texas Oncology - Seton-Williamson | Round Rock, Texas 78665 |
| Texas Oncology - Round Rock | Round Rock, Texas 78681 |
| Providence Health & Services | Portland, Oregon 97213 |
| Urology of Virginia, PLLC | Virginia Beach, Virginia 23462 |
| First Urology, PSC | Jeffersonville, Indiana 47130 |
| Tower Urology / Tower Research Institute | Los Angeles, California 90048 |
| 21st Century Oncology | Scottsdale, Arizona 85251 |
| Urologic Specialists of Oklahoma | Tulsa, Oklahoma 74146 |
| Associated Medical Professionals of NY, PLLC | Oneida, New York 13421 |
| Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center | Lincoln, Nebraska 68510 |
| National Translational Research Group, Inc. | East Setauket, New York 11733 |
| Raleigh Hematology Oncology Associates D.B.A., Cancer Centers of North Carolina | Raleigh, North Carolina 27614 |
| TriState Urologic Services PSC Inc., dba The Urology Group | Cincinnati, Ohio 45212 |
