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

Prostate Cancer Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01727154
• Other study ID #: P11-4
• Status: Terminated
• Start date: October 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2019
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 139
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Locations

Country	Name	City	State
United States	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania
United States	Tufts Medical Center	Boston	Massachusetts
United States	St. Louis Cancer Care, LLP	Bridgeton	Missouri
United States	Montefiore Medical Center	Bronx	New York
United States	TriState Urologic Services PSC Inc., dba The Urology Group	Cincinnati	Ohio
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	The Urology Center of Colorado	Denver	Colorado
United States	Henry Ford Health System	Detroit	Michigan
United States	National Translational Research Group, Inc.	East Setauket	New York
United States	Texas Oncology - Fort Worth	Fort Worth	Texas
United States	Carolina Urology Partners	Gastonia	North Carolina
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	First Urology, PSC	Jeffersonville	Indiana
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Tower Urology / Tower Research Institute	Los Angeles	California
United States	Prostate Oncology Specialists, Inc.	Marina Del Rey	California
United States	Delaware Valley Urology, LLC	Mount Laurel	New Jersey
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Providence Health & Services	Portland	Oregon
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Raleigh	North Carolina
United States	St. Louis Cancer Care, LLP	Saint Louis	Missouri
United States	21st Century Oncology	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Centerl	Seattle	Washington
United States	Highland Clinic	Shreveport	Louisiana
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals of NY, PLLC	Syracuse	New York
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Michigan Institute of Urology	Troy	Michigan
United States	Northwest Cancer Specialists, PC	Tualatin	Oregon
United States	Urologic Specialists of Oklahoma	Tulsa	Oklahoma
United States	Northwest Cancer Specialists	Vancouver	Washington
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Howard University Cancer Center	Washington	District of Columbia
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will 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).	Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.