Clinical trial NCT01727154: Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Official title: Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2012-11-15
Enrollment: 139
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.

Brief summary: The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
timeFrame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: 21st Century Oncology
state: Arizona
city: Los Angeles
country: United States
facility: Tower Urology / Tower Research Institute
state: California
city: Marina Del Rey
country: United States
facility: Prostate Oncology Specialists, Inc.
state: California
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Washington
country: United States
facility: Howard University Cancer Center
state: District of Columbia
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Shreveport
country: United States
facility: Highland Clinic
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Bridgeton
country: United States
facility: St. Louis Cancer Care, LLP
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Cancer Care, LLP
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Mount Laurel
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: East Setauket
country: United States
facility: National Translational Research Group, Inc.
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Gastonia
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
state: North Carolina
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc., dba The Urology Group
state: Ohio
city: Tulsa
country: United States
facility: Urologic Specialists of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Tualatin
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Columbia
country: United States
facility: South Carolina Oncology Associates
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth
state: Texas
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Centerl
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
Study officials:
affiliation: Dendreon Pharmaceuticals, LLC
name: Bruce Brown, MD
role: STUDY_DIRECTOR
References: