A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Prostatic Neoplasms Clinical Trial

— PROCEED  

Official title:

A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306890
• Other study ID #: P10-3
• Status: Completed
• Start date: January 27, 2011
• Est. completion date: January 17, 2017

Study information

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

Clinical Trial Summary

The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.

Description:

Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1976
• Est. completion date: January 17, 2017
• Est. primary completion date: January 17, 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 advanced prostate cancer who will receive sipuleucel-T or who underwent their first leukapheresis for manufacture of sipuleucel-T = 6 months prior to enrollment

• subjects must understand and sign an informed consent form

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Advanced 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	Hendrick Medical Center / Hendrick Cancer Center	Abilene	Texas
United States	Texas Oncology-Abilene	Abilene	Texas
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	New Mexico Oncology Hematology Consultants, LTD	Albuquerque	New Mexico
United States	Georgia Cancer Specialists - Alpharetta	Alpharetta	Georgia
United States	Cancer Centers of Southwest Oklahoma	Altus	Oklahoma
United States	McFarland Clinic, PC	Ames	Iowa
United States	Asheville Hematology & Oncology	Asheville	North Carolina
United States	Georgia Cancer Specialists - Athens	Athens	Georgia
United States	Atlanta Hematology Oncology Associates	Atlanta	Georgia
United States	Emory University Hospital, The Emory Clinic, Winship Cancer Institute	Atlanta	Georgia
United States	Georgia Cancer Specialists - Emory Midtown	Atlanta	Georgia
United States	Georgia Urology, PA	Atlanta	Georgia
United States	Midtown Urology	Atlanta	Georgia
United States	Peachtree Hematology-Oncology Consultants, PC	Atlanta	Georgia
United States	Piedmont West	Atlanta	Georgia
United States	Augusta Oncology Associates, PC	Augusta	Georgia
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	Northwest Georgia Oncology Centers, P.C.	Austell	Georgia
United States	Texas Oncolocy - South Austin	Austin	Texas
United States	Texas Oncology - Austin Midtown	Austin	Texas
United States	Texas Oncology - Austin North	Austin	Texas
United States	Mount Sinai Comprehensive Cancer Center	Aventura	Florida
United States	Urologic Consultants of SE PA	Bala-Cynwyd	Pennsylvania
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Family Cancer Center Foundation, Inc.	Bartlett	Tennessee
United States	Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Birmingham Hematology and Oncology Associates, LLC	Bessemer	Alabama
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	Birmingham Hematology and Oncology Associates, LLC	Birmingham	Alabama
United States	New Jersey Urology, LLC	Bloomfield	New Jersey
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Steward Sr. Elizabeth's Medical Center of Boston Inc.	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Rocky Mountain Cancer Centers	Boulder	Colorado
United States	Manatee Medical Research Institute, LLC	Bradenton	Florida
United States	St. Louis Cancer Care, LLP	Bridgeton	Missouri
United States	Albert Einstein Cancer Center at the Montefiore Medical Park	Bronx	New York
United States	Eastchester Center for Cancer Care	Bronx	New York
United States	Montefiore Medical Center	Bronx	New York
United States	Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital	Brookfield	Wisconsin
United States	Henry Ford Medical Center - Woodhaven	Brownstown	Michigan
United States	Urology Health Specialists, LLC	Bryn Mawr	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	The Jonah Center	Buffalo	New York
United States	Zale P. Bernstein, MD, PC	Buffalo	New York
United States	Minnesota Oncology Hematology, P.A.	Burnsville	Minnesota
United States	Northwest Georgia Oncology Centers, P.C.	Carrollton	Georgia
United States	Northwest Georgia Oncology Centers, P.C.	Cartersville	Georgia
United States	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Cary	North Carolina
United States	Texas Oncology - Cedar Park	Cedar Park	Texas
United States	Physician's Clinic of Iowa, P.C.	Cedar Rapids	Iowa
United States	Ironwood Cancer and Research	Chandler	Arizona
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Presbyterian Hospital Cancer Center	Charlotte	North Carolina
United States	St. Louis Cancer Care, LLP	Chesterfield	Missouri
United States	South County Hematology/Oncology	Chula Vista	California
United States	TriState Urologic Services PSC, Inc. dba TUG Research	Cincinnati	Ohio
United States	Rocky Mountain Cancer Centers	Colorado Springs	Colorado
United States	Rocky Mountain Cancer Centers	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center - University of Missouri Health Care	Columbia	Missouri
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	John B. Amos Cancer Center	Columbus	Georgia
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Minnesota Oncology Hematology, P.A.	Coon Rapids	Minnesota
United States	Wilshire Oncology Medical Group, Inc.	Corona	California
United States	Cancer Specialists of South Texas, PA	Corpus Christi	Texas
United States	Heartland Oncology & Hematology, PLLC	Council Bluffs	Iowa
United States	21st Century Oncology	Crestview	Florida
United States	Louisiana Oncology Associates	Crowley	Louisiana
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas
United States	Urology Clinics of North Texas, PLLC	Dallas	Texas
United States	Henry Ford Medical Center - Fairlane	Dearborn	Michigan
United States	Georgia Cancer Specialists - Stemmer	Decatur	Georgia
United States	Texas Oncology - Denton South	Denton	Texas
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	Rocky Mountain Cancer Centers	Denver	Colorado
United States	The Urology Center of Colorado	Denver	Colorado
United States	Oncology and Hematology Specialists, P.A.	Denville	New Jersey
United States	Henry Ford Hospital	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Northwest Georgia Oncology Centers, P.C.	Douglasville	Georgia
United States	Gwinnett Hospital System Inc. dba Center for Cancer Care	Duluth	Georgia
United States	Cancer Centers of Southwest Oklahoma	Duncan	Oklahoma
United States	Duke University Medical Center - Duke South Clinics	Durham	North Carolina
United States	Regional Cancer Care, P.A.	Durham	North Carolina
United States	North Shore Hematology/Oncology Associates	East Setauket	New York
United States	Minnesota Oncology Hematology, P.A.	Edina	Minnesota
United States	Texas Oncology - El Paso Cancer Treatment Center Gateway	El Paso	Texas
United States	Texas Oncology - El Paso Cancer Treatment Center Grandview	El Paso	Texas
United States	Texas Oncology - El Paso Cancer Treatment Center Joe Battle	El Paso	Texas
United States	Elkhart Clinic	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Urology Specialists of Southern California	Encino	California
United States	The Regional Cancer Center	Erie	Pennsylvania
United States	Urological Associates, Inc.	Evansville	Indiana
United States	Karmanos Cancer Institute at Farmington Hills	Farmington Hills	Michigan
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Georgia Cancer Specialists - Fayetteville	Fayetteville	Georgia
United States	Integrated Community Oncology Network	Fleming Island	Florida
United States	21st Century Oncology	Fort Myers	Florida
United States	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana
United States	Texas Oncology - Fort Worth 12th Avenue	Fort Worth	Texas
United States	Texas Oncology - Southwest Fort Worth	Fort Worth	Texas
United States	Robert A. Moss, M.D., F.A.C.P., Inc	Fountain Valley	California
United States	Wheaton Franciscan Healthcare - Reiman Cancer Center	Franklin	Wisconsin
United States	Queens Medical Associates	Fresh Meadows	New York
United States	Minnesota Oncology Hematology, P.A.	Fridley	Minnesota
United States	Carolina Urology Partners	Gastonia	North Carolina
United States	The Jones Clinic, PC	Germantown	Tennessee
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	Pacific Shores Medical Group	Glendale	California
United States	Palo Verde Cancer Specialists	Glendale	Arizona
United States	Wilshire Oncology Medical Group, Inc.	Glendora	California
United States	Western Oncology/Hematology Associates, PC	Golden	Colorado
United States	Weatern Regional Medical Center / Cancer Treatment Centers of America	Goodyear	Arizona
United States	Myron I Murdock MD LLC	Greenbelt	Maryland
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	Memorial Hennann Hosptial - Southwest Cancer Center	Houston	Texas
United States	UTHealth Oncology, Memorial Hermann Cancer Center	Houston	Texas
United States	Florida Cancer Specialists, PL	Hudson	Florida
United States	Memorial Hennann Hospital - Northeast Cancer Center	Humble	Texas
United States	Presbyterian Hospital Huntersville	Huntersville	North Carolina
United States	Pacific Shores Medical Group	Huntington Beach	California
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	Integrated Community Oncology Network	Jacksonville Beach	Florida
United States	Metropolitan Urology Clinical Research	Jeffersonville	Indiana
United States	Joliet Oncology-Hematology Associates, Ltd.	Joliet	Illinois
United States	Urological Surgeons of Illinois	Kankakee	Illinois
United States	Saint Luke's Cancer Institute, Saint Luke's Hospital	Kansas City	Missouri
United States	Texas Oncology - Kyle	Kyle	Texas
United States	Moores UCSD Cancer Center	La Jolla	California
United States	UCSD Medical Center - La Jolla	La Jolla	California
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Cancer Center Oncology Medical Group	La Mesa	California
United States	Wilshire Oncology Medical Group, Inc.	La Verne	California
United States	Louisiana Oncology Associates	Lafayette	Louisiana
United States	Watson Clinic LLP, Center for Cancer Care & Research, Clark & Daughtrey Medical Group, PA	Lakeland	Florida
United States	Rocky Mountain Cancer Centers	Lakewood	Colorado
United States	Urological Associates of Lancaster	Lancaster	Pennsylvania
United States	Indiana University Health La Porte Hospital	LaPorte	Indiana
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Gwinnett Hospital System Inc. dba Center for Cancer Care	Lawrenceville	Georgia
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Texas Oncology - Lewisville	Lewisville	Texas
United States	Nebraska Hematology-Oncology, PC	Lincoln	Nebraska
United States	Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center	Lincoln	Nebraska
United States	Little Rock Hematology Oncology: A Division of CARTI	Little Rock	Arkansas
United States	Rocky Mountain Cancer Centers	Littleton	Colorado
United States	Rocky Mountain Cancer Centers	Lone Tree	Colorado
United States	Pacific Shores Medical Group	Long Beach	California
United States	Rocky Mountain Cancer Centers	Longmont	Colorado
United States	Pacific Shores Medical Group	Los Alamitos	California
United States	Tower Urology	Los Angeles	California
United States	UCLA Institute of Urologic Oncology, UCLA Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California
United States	Jewish Hospital & St. Mary's Healthcare	Louisville	Kentucky
United States	Northwest Florida Hematology Oncology PA	Lynn Haven	Florida
United States	Georgia Cancer Specialists - Macon	Macon	Georgia
United States	Minnesota Oncology Hematology, P.A.	Maplewood	Minnesota
United States	Georgia Cancer Specialists - Kennestone	Marietta	Georgia
United States	Northwest Georgia Oncology Centers, P.C.	Marietta	Georgia
United States	Urology Enterprises	Marietta	Georgia
United States	Prostate Oncology Speciality Inc.	Marina Del Rey	California
United States	Matthews Hematology Oncology Associates	Matthews	North Carolina
United States	Presbyterian Hospital Matthews	Matthews	North Carolina
United States	Family Cancer Center Foundation, Inc.	Memphis	Tennessee
United States	Family Cancer Center Foundation, Inc.	Memphis	Tennessee
United States	The West Clinic	Memphis	Tennessee
United States	Advanced Medical Specialties	Miami	Florida
United States	Advanced Medical Specialties	Miami	Florida
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	SouthWest Urology	Middleburg Heights	Ohio
United States	Wheaton Franciscan Healthcare - St. Francis Hospital	Milwaukee	Wisconsin
United States	Wheaton Franciscan Healthcare - St. Joseph's Hospital	Milwaukee	Wisconsin
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	Lake Norman Hematology Oncology Specialists	Mooresville	North Carolina
United States	Hematology-Oncology Associates of Northern NJ, PA; Carol G. Simon Cancer Center	Morristown	New Jersey
United States	Delaware Valley Urology, LLC	Mount Laurel	New Jersey
United States	Tri Valley Urology Medical Group	Murrieta	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	21st Century Oncology	Naples	Florida
United States	Premier Oncology	Naples	Florida
United States	Tennessee Oncology, Centennial Medical Center	Nashville	Tennessee
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	The Jones Clinic, PC	New Albany	Mississippi
United States	Coastal Carolina Health Care, PA, dba New Bern Cancer Care	New Bern	North Carolina
United States	Grove Hill Clinical Research, Grove Hill Medical Center, Urology Center of Grove Hill	New Britain	Connecticut
United States	Yale Urology	New Haven	Connecticut
United States	Louisiana Oncology Associates	New Iberia	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Florida Cancer Specialists, PL	New Port Richey	Florida
United States	NYU Clinical Cancer Center	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Lakeland Hospital	Niles	Michigan
United States	Oncology Specialists, S.C.	Niles	Illinois
United States	Urology of Virginia / SMG	Norfolk	Virginia
United States	Mid-Illinois Hematology & Oncology Associates, LTD	Normal	Illinois
United States	Integrated Medical Professionals	North Hills	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Eastern Connecticut Hematology and Oncology Associates	Norwich	Connecticut
United States	Henry Ford Medical Center - Columbus Center	Novi	Michigan
United States	Ocala Oncology Center	Ocala	Florida
United States	North County Oncology Medical Group, Inc.	Oceanside	California
United States	MedStar Montgomery Medical Center	Olney	Maryland
United States	Oncology Hematology West, PC dba Nebraska Cancer Specialists	Omaha	Nebraska
United States	Urology Cancer Center & GU Research Network	Omaha	Nebraska
United States	Louisiana Oncology Associates	Opelousas	Louisiana
United States	Hematology-Oncology Medical Group of Orange County, Inc.	Orange	California
United States	Medical Oncology Care Associates (MOCA)	Orange	California
United States	The Center for Cancer Prevention and Treatment, St. Joseph Hospital	Orange	California
United States	Atlantic Urological Associates	Orange City	Florida
United States	Integrated Community Oncology Network	Orange Park	Florida
United States	Kansas City Urology Care	Overland Park	Kansas
United States	Family Cancer Center Foundation, Inc.	Oxford	Mississippi
United States	PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists	Oxnard	California
United States	Integrated Community Oncology Network	Palatka	Florida
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Advanced Urology, PC	Parker	Colorado
United States	Rocky Mountain Cancer Centers	Parker	Colorado
United States	Wilshire Oncology Medical Group, Inc.	Pasadena	California
United States	Sacred Heart Medical Oncology Groupl	Pensacola	Florida
United States	UPMC Cancer Center / Hillman Cancer Centerl	Pittsburgh	Pennsylvania
United States	Michiana Hematology Oncology, P. C.	Plymouth	Indiana
United States	Wilshire Oncology Medical Group, Inc.	Pomona	California
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Northwest Cancer Specialists, P.C.	Portland	Oregon
United States	Providence Cancer Center Oncology and Hematology Care	Portland	Oregon
United States	Premier Medical Group of the Hudson Valley	Poughkeepsie	New York
United States	Harrison Poulsbo Hematology & Oncology	Poulsbo	Washington
United States	Rocky Mountain Cancer Centers	Pueblo	Colorado
United States	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Wilshire Oncology Medical Group, Inc.	Rancho Cucamonga	California
United States	Hubert H. Humphrey Cancer Center	Robbinsdale	Minnesota
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	Harbin Clinic	Rome	Georgia
United States	Sutter Roseville Medical Center	Roseville	California
United States	Texas Oncology - Round Rock	Round Rock	Texas
United States	Texas Oncology - Seton-Williamson	Round Rock	Texas
United States	Sutter Cancer Center / Sacramento Center for Hematology and Medical Oncology	Sacramento	California
United States	Sutter Memorial Hospital	Sacramento	California
United States	Integrated Community Oncology Network	Saint Augustine	Florida
United States	Michgan Institute of Urology, PC	Saint Clair Shores	Michigan
United States	Lakeland Hospital	Saint Joseph	Michigan
United States	Marie Yeager Cancer Center	Saint Joseph	Michigan
United States	Comprehensive Cancer Care	Saint Louis	Missouri
United States	St. Louis Cancer Care, LLP	Saint Louis	Missouri
United States	Minnesota Oncology Hematology, P.A.	Saint Paul	Minnesota
United States	Huntsman Cancer Hospital	Salt Lake City	Utah
United States	Oncology San Antonio Research, LLC	San Antonio	Texas
United States	Urology San Antonio Research	San Antonio	Texas
United States	Genesis Research	San Diego	California
United States	Medical Oncology Associates	San Diego	California
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Sharp Rees-Stealy	San Diego	California
United States	UCSD Medical Center - Hillcrest	San Diego	California
United States	Texas Oncology - San Marcos	San Marcos	Texas
United States	Georgia Cancer Specialists - Northside	Sandy Springs	Georgia
United States	Edward Alexson, MD, Inc.	Santa Ana	California
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Adult and Pediatric Urology	Sartell	Minnesota
United States	21st Century Oncology	Scottsdale	Arizona
United States	Pinnacle Oncology Hematology, Oncology Research Associates, PLLC	Scottsdale	Arizona
United States	Scranton Hematology Oncology	Scranton	Pennsylvania
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Northwest Louisiana Oncology Associates Of Highland Clinic	Shreveport	Louisiana
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Avera Cancer Institute, Avera Medical Group Oncology and Hematology	Sioux Falls	South Dakota
United States	Gwinnett Hospital System Inc. dba Center for Cancer Care	Snellville	Georgia
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Northern Indiana Cancer Research Consortium, Michiana Hematology Oncology, P.C.	South Bend	Indiana
United States	Family Cancer Center Foundation, Inc.	Southaven	Mississippi
United States	Sparta Cancer Center	Sparta	New Jersey
United States	Urology Center of Spartanburg	Spartanburg	South Carolina
United States	Medical Oncology Associates, PS	Spokane	Washington
United States	Oregon Urology Institute	Springfield	Oregon
United States	The Stamford Hospital	Stamford	Connecticut
United States	Staten Island Urological Research, PC	Staten Island	New York
United States	Georgia Cancer Specialists - Stockbridge	Stockbridge	Georgia
United States	Stockton Hematology Oncology Medical Group	Stockton	California
United States	Associated Medical Professionals of New York, PLLC	Syracuse	New York
United States	Southeastern Research Group, Inc.	Tallahassee	Florida
United States	Rocky Mountain Cancer Centers	Thornton	Colorado
United States	Michigan Institute of Urology, PC	Troy	Michigan
United States	Northwest Cancer Specialists, P.C.	Tualatin	Oregon
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	Arizona Oncology Associates, PC - HOPE	Tucson	Arizona
United States	El Dorado Research	Tucson	Arizona
United States	Urological Associates of Southern Arizona, P.C.	Tucson	Arizona
United States	Urologic Specialists of Oklahoma	Tulsa	Oklahoma
United States	Blood and Cancer Center of East Texas	Tyler	Texas
United States	Michigan Institute of Urology, PC	Utica	Michigan
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Northwest Cancer Specialists, P.C.	Vancouver	Washington
United States	Contra Costa Oncology	Walnut Creek	California
United States	Georgetown University Hospital	Washington	District of Columbia
United States	Howard University Cancer Center & Howeard University Hospital	Washington	District of Columbia
United States	Wheaton Franciscan Healthcare -Wauwatosa Cancer Care	Wauwatosa	Wisconsin
United States	Texas Oncology - Deke Slayton Cancer Center	Webster	Texas
United States	Henry Ford Medical Center- West Bloomfield	West Bloomfield	Michigan
United States	Lexington Oncology Associates, LLC	West Columbia	South Carolina
United States	Wilshire Oncology Medical Group, Inc.	West Covina	California
United States	Urology Group of New Jersey	West Orange	New Jersey
United States	Michiana Hematology Oncology, P. C.	Westville	Indiana
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Wichita Urology Group P.A	Wichita	Kansas
United States	Minnesota Oncology Hematology, P.A.	Woodbury	Minnesota
United States	Cancer Care Associates of York	York	Pennsylvania
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects	The incidence rate of CVEs (cardiovascular events) was estimated as the number of new events per 100 patient years of follow-up in the overall sample of men with advanced-stage or metastatic prostate cancer and in men with or without castration.	Every 3 months for a minimum of 3 years
Secondary	Survival	To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.	Every 3 months for a minimum of 3 years