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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 NevadaLas Vegas, Nevada  89109
Michigan Institute of UrologyDetroit, Michigan  48236
Henry Ford Health SystemDetroit, Michigan  48202
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Cancer Center of KansasWichita, Kansas  67214
Karmanos Cancer CenterDetroit, Michigan  48201
Tulane UniversityNew Orleans, Louisiana  70112-2699
Oregon Urology InstituteSpringfield, Oregon  97477
The Urology Center of ColoradoDenver, Colorado  80211
St. Louis Cancer Care, LLPChesterfield, Missouri  63017
21st Century OncologyCape Coral, Florida  33990
Prostate Oncology Specialists, Inc.Marina Del Rey, California  90292
Arizona Oncology Associates, PC - HOPETucson, Arizona  85704
Texas Oncology - Austin MidtownAustin, Texas  78705
Texas Oncology - Austin CentralAustin, Texas  78731
Karmanos Cancer Institute at Farmington HillsFarmington Hills, Michigan  48334
Premier Medical Group of the Hudson ValleyPoughkeepsie, New York  12601
Urology Cancer Center & GU Research NetworkOmaha, Nebraska  68130
Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North CarolinaCary, North Carolina  27518
Urology Associates, P.C.Nashville, Tennessee  37209
Texas Oncolocy - South AustinAustin, Texas  78745
Texas Oncology - Austin NorthAustin, Texas  78758
Texas Oncology - Cedar ParkCedar Park, Texas  78613
Texas Oncology - Seton-WilliamsonRound Rock, Texas  78665
Texas Oncology - Round RockRound Rock, Texas  78681
Providence Health & ServicesPortland, Oregon  97213
Urology of Virginia, PLLCVirginia Beach, Virginia  23462
First Urology, PSCJeffersonville, Indiana  47130
Tower Urology / Tower Research InstituteLos Angeles, California  90048
21st Century OncologyScottsdale, Arizona  85251
Urologic Specialists of OklahomaTulsa, Oklahoma  74146
Associated Medical Professionals of NY, PLLCOneida, New York  13421
Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
National Translational Research Group, Inc.East Setauket, New York  11733
Raleigh Hematology Oncology Associates D.B.A., Cancer Centers of North CarolinaRaleigh, North Carolina  27614
TriState Urologic Services PSC Inc., dba The Urology GroupCincinnati, Ohio  45212