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

March 5, 2019 updated by: Dendreon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Biological: sipuleucel-T

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1976

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Bessemer, Alabama, United States, 35022
    - Birmingham Hematology and Oncology Associates, LLC
  - Birmingham, Alabama, United States, 35205
    - Birmingham Hematology and Oncology Associates, LLC
  - Birmingham, Alabama, United States, 35235
    - Birmingham Hematology and Oncology Associates, LLC
  - Birmingham, Alabama, United States, 35213
    - Birmingham Hematology and Oncology Associates, LLC
  - Birmingham, Alabama, United States, 35211
    - Birmingham Hematology and Oncology Associates, LLC
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute
- Arizona
  - Chandler, Arizona, United States, 85224-5665
    - Ironwood Cancer and Research
  - Glendale, Arizona, United States, 85304
    - Palo Verde Cancer Specialists
  - Goodyear, Arizona, United States, 85338
    - Weatern Regional Medical Center / Cancer Treatment Centers of America
  - Scottsdale, Arizona, United States, 85251
    - 21st Century Oncology
  - Scottsdale, Arizona, United States, 85258
    - Pinnacle Oncology Hematology, Oncology Research Associates, PLLC
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology Associates, PC - HOPE
  - Tucson, Arizona, United States, 85710
    - Arizona Oncology Associates, PC - HOPE
  - Tucson, Arizona, United States, 85712
    - Arizona Oncology Associates, PC - HOPE
  - Tucson, Arizona, United States, 85715
    - El Dorado Research
  - Tucson, Arizona, United States, 85715
    - Urological Associates of Southern Arizona, P.C.
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Little Rock Hematology Oncology: A Division of CARTI
- California
  - Chula Vista, California, United States, 91911
    - South County Hematology/Oncology
  - Corona, California, United States, 92879
    - Wilshire Oncology Medical Group, Inc.
  - Encino, California, United States, 91436-2140
    - Urology Specialists of Southern California
  - Fountain Valley, California, United States, 92708
    - ROBERT A. MOSS, M.D., F.A.C.P., Inc
  - Glendale, California, United States, 91204
    - Pacific Shores Medical Group
  - Glendora, California, United States, 91741
    - Wilshire Oncology Medical Group, Inc.
  - Huntington Beach, California, United States, 92648
    - Pacific Shores Medical Group
  - La Jolla, California, United States, 92093
    - Moores UCSD Cancer Center
  - La Jolla, California, United States, 92093-0820
    - UCSD Moores Cancer Center
  - La Jolla, California, United States, 92037
    - UCSD Medical Center - La Jolla
  - La Mesa, California, United States, 91942
    - Cancer Center Oncology Medical Group
  - La Verne, California, United States, 91750
    - Wilshire Oncology Medical Group, Inc.
  - Long Beach, California, United States, 90813
    - Pacific Shores Medical Group
  - Los Alamitos, California, United States, 90720
    - Pacific Shores Medical Group
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90048
    - Tower Urology
  - Los Angeles, California, United States, 90024
    - UCLA Institute of Urologic Oncology, UCLA Medical Center
  - Marina Del Rey, California, United States, 90292
    - Prostate Oncology Speciality Inc.
  - Murrieta, California, United States, 92562
    - Tri Valley Urology Medical Group
  - Oceanside, California, United States, 92056
    - North County Oncology Medical Group, Inc.
  - Orange, California, United States, 92868
    - Hematology-Oncology Medical Group of Orange County, Inc.
  - Orange, California, United States, 92868
    - Medical Oncology Care Associates (MOCA)
  - Orange, California, United States, 92868
    - The Center for Cancer Prevention and Treatment, St. Joseph Hospital
  - Oxnard, California, United States, 93030
    - PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists
  - Pasadena, California, United States, 91105
    - Wilshire Oncology Medical Group, Inc.
  - Pomona, California, United States, 91767
    - Wilshire Oncology Medical Group, Inc.
  - Rancho Cucamonga, California, United States, 91730
    - Wilshire Oncology Medical Group, Inc.
  - Roseville, California, United States, 95677
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Cancer Center / Sacramento Center for Hematology and Medical Oncology
  - Sacramento, California, United States, 95819-3223
    - Sutter Memorial Hospital
  - San Diego, California, United States, 92123
    - Sharp Clinical Oncology Research
  - San Diego, California, United States, 92123
    - Sharp Rees-Stealy
  - San Diego, California, United States, 92123
    - Genesis Research
  - San Diego, California, United States, 92103
    - UCSD Medical Center - Hillcrest
  - San Diego, California, United States, 92123
    - Medical Oncology Associates
  - Santa Ana, California, United States, 92705
    - Edward Alexson, Md, Inc.
  - Stockton, California, United States, 95204
    - Stockton Hematology Oncology Medical Group
  - Walnut Creek, California, United States, 94598
    - Contra Costa Oncology
  - West Covina, California, United States, 91790
    - Wilshire Oncology Medical Group, Inc.
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers
  - Colorado Springs, Colorado, United States, 80909
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80211
    - The Urology Center of Colorado
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers
  - Golden, Colorado, United States, 80401
    - Western Oncology/Hematology Associates, PC
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers
  - Littleton, Colorado, United States, 80120-4413
    - Rocky Mountain Cancer Centers
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers
  - Parker, Colorado, United States, 80134
    - Advanced Urology, PC
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers
- Connecticut
  - New Britain, Connecticut, United States, 06052
    - Grove Hill Clinical Research, Grove Hill Medical Center, Urology Center of Grove Hill
  - New Haven, Connecticut, United States, 06511
    - Yale Urology
  - Norwalk, Connecticut, United States, 06856
    - Norwalk Hospital
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology and Oncology Associates
  - Stamford, Connecticut, United States, 06902
    - The Stamford Hospital
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Georgetown University Hospital
  - Washington, District of Columbia, United States, 20060
    - Howard University Cancer Center & Howeard University Hospital
- Florida
  - Aventura, Florida, United States, 33180
    - Mount Sinai Comprehensive Cancer Center
  - Bradenton, Florida, United States, 34205
    - Manatee Medical Research Institute, LLC
  - Crestview, Florida, United States, 32539
    - 21st Century Oncology
  - Fleming Island, Florida, United States, 32003
    - Integrated Community Oncology Network
  - Fort Myers, Florida, United States, 33907
    - 21st Century Oncology
  - Hudson, Florida, United States, 34667
    - Florida Cancer Specialists, PL
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32258
    - Integrated Community Oncology Network
  - Jacksonville, Florida, United States, 32204
    - Integrated Community Oncology Network
  - Jacksonville, Florida, United States, 32207
    - Integrated Community Oncology Network
  - Jacksonville Beach, Florida, United States, 32250
    - Integrated Community Oncology Network
  - Lakeland, Florida, United States, 33805
    - Watson Clinic LLP, Center for Cancer Care & Research, Clark & Daughtrey Medical Group, PA
  - Lynn Haven, Florida, United States, 32444
    - Northwest Florida Hematology Oncology PA
  - Miami, Florida, United States, 33176
    - Advanced Medical Specialties
  - Miami, Florida, United States, 33143
    - Advanced Medical Specialties
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Comprehensive Cancer Center
  - Naples, Florida, United States, 34102
    - 21st Century Oncology
  - Naples, Florida, United States, 34102
    - Premier Oncology
  - New Port Richey, Florida, United States, 34655
    - Florida Cancer Specialists, PL
  - Ocala, Florida, United States, 33471
    - Ocala Oncology Center
  - Orange City, Florida, United States, 32763
    - Atlantic Urological Associates
  - Orange Park, Florida, United States, 32073
    - Integrated Community Oncology Network
  - Palatka, Florida, United States, 32177
    - Integrated Community Oncology Network
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Medical Oncology Groupl
  - Saint Augustine, Florida, United States, 32086
    - Integrated Community Oncology Network
  - Tallahassee, Florida, United States, 32308
    - Southeastern Research Group, Inc.
- Georgia
  - Alpharetta, Georgia, United States, 30005
    - Georgia Cancer Specialists - Alpharetta
  - Athens, Georgia, United States, 30606
    - Georgia Cancer Specialists - Athens
  - Atlanta, Georgia, United States, 30318
    - Peachtree Hematology-Oncology Consultants, PC
  - Atlanta, Georgia, United States, 30308
    - Midtown Urology
  - Atlanta, Georgia, United States, 30342
    - Georgia Urology, PA
  - Atlanta, Georgia, United States, 30308
    - Georgia Cancer Specialists - Emory Midtown
  - Atlanta, Georgia, United States, 30309-1710
    - Atlanta Hematology Oncology Associates
  - Atlanta, Georgia, United States, 30318
    - Piedmont West
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital, The Emory Clinic, Winship Cancer Institute
  - Augusta, Georgia, United States, 30901
    - Augusta Oncology Associates, PC
  - Austell, Georgia, United States, 30106
    - Northwest Georgia Oncology Centers, P.C.
  - Carrollton, Georgia, United States, 30117
    - Northwest Georgia Oncology Centers, P.C.
  - Cartersville, Georgia, United States, 30121
    - Northwest Georgia Oncology Centers, P.C.
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Georgia Cancer Specialists - Stemmer
  - Douglasville, Georgia, United States, 30134
    - Northwest Georgia Oncology Centers, P.C.
  - Duluth, Georgia, United States, 30096
    - Gwinnett Hospital System Inc. dba Center for Cancer Care
  - Fayetteville, Georgia, United States, 30215
    - Georgia Cancer Specialists - Fayetteville
  - Lawrenceville, Georgia, United States, 30046
    - Gwinnett Hospital System Inc. dba Center for Cancer Care
  - Macon, Georgia, United States, 31217
    - Georgia Cancer Specialists - Macon
  - Marietta, Georgia, United States, 30060
    - Urology Enterprises
  - Marietta, Georgia, United States, 30060
    - Northwest Georgia Oncology Centers, P.C.
  - Marietta, Georgia, United States, 30060
    - Georgia Cancer Specialists - Kennestone
  - Rome, Georgia, United States, 30165
    - Harbin Clinic
  - Sandy Springs, Georgia, United States, 30342
    - Georgia Cancer Specialists - Northside
  - Snellville, Georgia, United States, 30078
    - Gwinnett Hospital System Inc. dba Center for Cancer Care
  - Stockbridge, Georgia, United States, 30281
    - Georgia Cancer Specialists - Stockbridge
- Illinois
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Ltd.
  - Kankakee, Illinois, United States, 60901
    - Urological Surgeons of Illinois
  - Niles, Illinois, United States, 60714
    - Oncology Specialists, S.C.
  - Normal, Illinois, United States, 61761
    - Mid-Illinois Hematology & Oncology Associates, Ltd
  - Park Ridge, Illinois, United States, 60068
    - Oncology Specialists, S.C.
  - Zion, Illinois, United States, 60099
    - Midwestern Regional Medical Center
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Elkhart Clinic
  - Evansville, Indiana, United States, 47714
    - Urological Associates, Inc.
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology, Inc.
  - Jeffersonville, Indiana, United States, 47130
    - Metropolitan Urology Clinical Research
  - LaPorte, Indiana, United States, 46350
    - Indiana University Health La Porte Hospital
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology, P. C.
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Northern Indiana Cancer Research Consortium, Michiana Hematology Oncology, P.C.
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology, P. C.
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Cedar Rapids, Iowa, United States, 52401
    - Physician's Clinic of Iowa, P.C.
  - Council Bluffs, Iowa, United States, 51503
    - Heartland Oncology & Hematology, PLLC
- Kansas
  - Overland Park, Kansas, United States, 66211
    - Kansas City Urology Care
  - Westwood, Kansas, United States, 66205
    - University of Kansas Cancer Center
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas
  - Wichita, Kansas, United States, 67226
    - Wichita Urology Group P.A
- Kentucky
  - Louisville, Kentucky, United States, 40245
    - Jewish Hospital & St. Mary's Healthcare
- Louisiana
  - Crowley, Louisiana, United States, 70526
    - Louisiana Oncology Associates
  - Lafayette, Louisiana, United States, 70508
    - Louisiana Oncology Associates
  - New Iberia, Louisiana, United States, 70560
    - Louisiana Oncology Associates
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
  - Opelousas, Louisiana, United States, 70570
    - Louisiana Oncology Associates
  - Shreveport, Louisiana, United States, 71106
    - Regional Urology, LLC
  - Shreveport, Louisiana, United States, 71105
    - Northwest Louisiana Oncology Associates Of Highland Clinic
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Chesapeake Urology Research Associates
  - Bethesda, Maryland, United States, 20889
    - Walter Reed National Military Medical Center
  - Greenbelt, Maryland, United States, 20770
    - Myron I Murdock MD LLC
  - Olney, Maryland, United States, 20832
    - MedStar Montgomery Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Boston, Massachusetts, United States, 02135
    - Steward Sr. Elizabeth's Medical Center of Boston Inc.
- Michigan
  - Brownstown, Michigan, United States, 48183
    - Henry Ford Medical Center - Woodhaven
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center - Fairlane
  - Detroit, Michigan, United States, 48201
    - Karmanos Cancer Institute
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Farmington Hills, Michigan, United States, 48334
    - Karmanos Cancer Institute at Farmington Hills
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital
  - Novi, Michigan, United States, 48377
    - Henry Ford Medical Center - Columbus Center
  - Saint Clair Shores, Michigan, United States, 48081
    - Michgan Institute of Urology, PC
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085-2158
    - Lakeland Hospital
  - Troy, Michigan, United States, 48084
    - Michigan Institute of Urology, PC
  - Utica, Michigan, United States, 48317
    - Michigan Institute of Urology, PC
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford Medical Center- West Bloomfield
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology Hematology, P.A.
  - Coon Rapids, Minnesota, United States, 55433
    - Minnesota Oncology Hematology, P.A.
  - Edina, Minnesota, United States, 55435-2150
    - Minnesota Oncology Hematology, P.A.
  - Fridley, Minnesota, United States, 55432
    - Minnesota Oncology Hematology, P.A.
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology, P.A.
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology, P.A.
  - Robbinsdale, Minnesota, United States, 55422
    - Hubert H. Humphrey Cancer Center
  - Saint Paul, Minnesota, United States, 55102-2389
    - Minnesota Oncology Hematology, P.A.
  - Sartell, Minnesota, United States, 56377
    - Adult and Pediatric Urology
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology, P.A.
- Mississippi
  - New Albany, Mississippi, United States, 38652
    - The Jones Clinic, PC
  - Oxford, Mississippi, United States, 38655
    - Family Cancer Center Foundation, Inc.
  - Southaven, Mississippi, United States, 38671
    - Family Cancer Center Foundation, Inc.
- Missouri
  - Bridgeton, Missouri, United States, 63044
    - St. Louis Cancer Care, LLP
  - Chesterfield, Missouri, United States, 63017
    - St. Louis Cancer Care, LLP
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center - University of Missouri Health Care
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute, Saint Luke's Hospital
  - Saint Louis, Missouri, United States, 63127
    - St. Louis Cancer Care, LLP
  - Saint Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Nebraska Hematology-Oncology, PC
  - Lincoln, Nebraska, United States, 68510
    - Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center
  - Lincoln, Nebraska, United States, 68516
    - Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center
  - Omaha, Nebraska, United States, 68130
    - Urology Cancer Center & GU Research Network
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists
- Nevada
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada
  - Henderson, Nevada, United States, 89014
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center
- New Jersey
  - Bloomfield, New Jersey, United States, 07003
    - New Jersey Urology, LLC
  - Denville, New Jersey, United States, 07830
    - Oncology and Hematology Specialists, P.A.
  - Morristown, New Jersey, United States, 07962
    - Hematology-Oncology Associates of Northern NJ, PA; Carol G. Simon Cancer Center
  - Mount Laurel, New Jersey, United States, 08054
    - Delaware Valley Urology, LLC
  - Sparta, New Jersey, United States, 07871
    - Sparta Cancer Center
  - West Orange, New Jersey, United States, 07052
    - Urology Group of New Jersey
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - New Mexico Oncology Hematology Consultants, LTD
  - Santa Fe, New Mexico, United States, 87505
    - New Mexico Cancer Care Associates
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, P.C.
  - Albany, New York, United States, 12208
    - New York Oncology Hematology, P.C.
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center
  - Bronx, New York, United States, 10469
    - Eastchester Center for Cancer Care
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at the Montefiore Medical Park
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - Buffalo, New York, United States, 14215
    - The Jonah Center
  - Buffalo, New York, United States, 14215
    - Zale P. Bernstein, MD, PC
  - East Setauket, New York, United States, 11733
    - North Shore Hematology/Oncology Associates
  - Fresh Meadows, New York, United States, 11366
    - Queens Medical Associates
  - New York, New York, United States, 10016
    - Nyu Clinical Cancer Center
  - New York, New York, United States, 10016
    - NYU Langone Medical Center
  - North Hills, New York, United States, 11042
    - Integrated Medical Professionals
  - Poughkeepsie, New York, United States, 12601
    - Premier Medical Group of the Hudson Valley
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center
  - Staten Island, New York, United States, 10304
    - Staten Island Urological Research, PC
  - Syracuse, New York, United States, 13210
    - Associated Medical Professionals of New York, PLLC
- North Carolina
  - Asheville, North Carolina, United States, 28803
    - Asheville Hematology & Oncology
  - Cary, North Carolina, United States, 27518
    - Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Presbyterian Hospital Cancer Center
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center - Duke South Clinics
  - Durham, North Carolina, United States, 27704
    - Regional Cancer Care, P.A.
  - Fayetteville, North Carolina, United States, 28304
    - Cape Fear Valley Health System
  - Gastonia, North Carolina, United States, 28054-3456
    - Carolina Urology Partners
  - Huntersville, North Carolina, United States, 28078
    - Presbyterian Hospital Huntersville
  - Matthews, North Carolina, United States, 28105
    - Matthews Hematology Oncology Associates
  - Matthews, North Carolina, United States, 28105
    - Presbyterian Hospital Matthews
  - Mooresville, North Carolina, United States, 28117
    - Lake Norman Hematology Oncology Specialists
  - New Bern, North Carolina, United States, 28562
    - Coastal Carolina Health Care, PA, dba New Bern Cancer Care
  - Raleigh, North Carolina, United States, 27607
    - Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
  - Raleigh, North Carolina, United States, 27614
    - Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina
- Ohio
  - Cincinnati, Ohio, United States, 45212
    - TriState Urologic Services PSC, Inc. dba TUG Research
  - Columbus, Ohio, United States, 43210-1280
    - Ohio State University Comprehensive Cancer Center
  - Middleburg Heights, Ohio, United States, 44130
    - Southwest Urology
- Oklahoma
  - Altus, Oklahoma, United States, 73521
    - Cancer Centers of Southwest Oklahoma
  - Duncan, Oklahoma, United States, 73533
    - Cancer Centers of Southwest Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma
  - Tulsa, Oklahoma, United States, 74146
    - Urologic Specialists of Oklahoma
- Oregon
  - Portland, Oregon, United States, 97227
    - Northwest Cancer Specialists, P.C.
  - Portland, Oregon, United States, 97213
    - Providence Cancer Center Oncology And Hematology Care
  - Portland, Oregon, United States, 97213-2982
    - Northwest Cancer Specialists, P.C.
  - Portland, Oregon, United States, 97225
    - Northwest Cancer Specialists, P.C.
  - Springfield, Oregon, United States, 97477
    - Oregon Urology Institute
  - Tualatin, Oregon, United States, 97062
    - Northwest Cancer Specialists, P.C.
- Pennsylvania
  - Bala-Cynwyd, Pennsylvania, United States, 19004
    - Urologic Consultants of SE PA
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Urology Health Specialists, LLC
  - Erie, Pennsylvania, United States, 16505
    - The Regional Cancer Center
  - Gettysburg, Pennsylvania, United States, 17325
    - Gettysburg Cancer Center
  - Lancaster, Pennsylvania, United States, 17604
    - Urological Associates of Lancaster
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC Cancer Center / Hillman Cancer Centerl
  - Scranton, Pennsylvania, United States, 18510
    - Scranton Hematology Oncology
  - York, Pennsylvania, United States, 17403
    - Cancer Care Associates of York
- South Carolina
  - Charleston, South Carolina, United States, 29414
    - Charleston Hematology Oncology Associates, PA
  - Columbia, South Carolina, United States, 29210
    - South Carolina Oncology Associates, PA
  - Myrtle Beach, South Carolina, United States, 29572
    - Carolina Urologic Research Center
  - Spartanburg, South Carolina, United States, 29303
    - Urology Center of Spartanburg
  - West Columbia, South Carolina, United States, 29169
    - Lexington Oncology Associates, LLC
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute, Avera Medical Group Oncology and Hematology
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - Family Cancer Center Foundation, Inc.
  - Germantown, Tennessee, United States, 38138
    - The Jones Clinic, PC
  - Memphis, Tennessee, United States, 38120
    - The West Clinic
  - Memphis, Tennessee, United States, 38119
    - Family Cancer Center Foundation, Inc.
  - Memphis, Tennessee, United States, 38120
    - Family Cancer Center Foundation, Inc.
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center
  - Nashville, Tennessee, United States, 37209
    - Urology Associates, P.C.
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology, Centennial Medical Center
- Texas
  - Abilene, Texas, United States, 79601
    - Hendrick Medical Center / Hendrick Cancer Center
  - Abilene, Texas, United States, 79606-5208
    - Texas Oncology-Abilene
  - Austin, Texas, United States, 78705
    - Texas Oncology - Austin Midtown
  - Austin, Texas, United States, 78745
    - Texas Oncolocy - South Austin
  - Austin, Texas, United States, 78758
    - Texas Oncology - Austin North
  - Beaumont, Texas, United States, 77702-1449
    - Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center
  - Cedar Park, Texas, United States, 78613
    - Texas Oncology - Cedar Park
  - Corpus Christi, Texas, United States, 78412
    - Cancer Specialists Of South Texas, Pa
  - Dallas, Texas, United States, 75231
    - Texas Oncology - Dallas Presbyterian Hospital
  - Dallas, Texas, United States, 75246
    - Texas Oncology - Baylor Charles A. Sammons Cancer Center
  - Dallas, Texas, United States, 75231-4482
    - Urology Clinics of North Texas, PLLC
  - Denton, Texas, United States, 76210
    - Texas Oncology - Denton South
  - El Paso, Texas, United States, 79902
    - Texas Oncology - El Paso Cancer Treatment Center Grandview
  - El Paso, Texas, United States, 79915
    - Texas Oncology - El Paso Cancer Treatment Center Gateway
  - El Paso, Texas, United States, 79939
    - Texas Oncology - El Paso Cancer Treatment Center Joe Battle
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology - Fort Worth 12th Avenue
  - Fort Worth, Texas, United States, 76132
    - Texas Oncology - Southwest Fort Worth
  - Houston, Texas, United States, 77030
    - UTHealth Oncology, Memorial Hermann Cancer Center
  - Houston, Texas, United States, 77074
    - Memorial Hennann Hosptial - Southwest Cancer Center
  - Humble, Texas, United States, 77338
    - Memorial Hennann Hospital - Northeast Cancer Center
  - Kyle, Texas, United States, 78640
    - Texas Oncology - Kyle
  - Lewisville, Texas, United States, 75067
    - Texas Oncology - Lewisville
  - Round Rock, Texas, United States, 78681
    - Texas Oncology - Round Rock
  - Round Rock, Texas, United States, 78665
    - Texas Oncology - Seton-Williamson
  - San Antonio, Texas, United States, 78229
    - Urology San Antonio Research
  - San Antonio, Texas, United States, 78240
    - Oncology San Antonio Research, LLC
  - San Marcos, Texas, United States, 78666
    - Texas Oncology - San Marcos
  - Tyler, Texas, United States, 75701
    - Blood and Cancer Center of East Texas
  - Webster, Texas, United States, 77598-4420
    - Texas Oncology - Deke Slayton Cancer Center
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Hospital
- Virginia
  - Norfolk, Virginia, United States, 23502
    - Urology of Virginia / SMG
- Washington
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology & Oncology
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98109
    - University of Washington
  - Spokane, Washington, United States, 99208
    - Medical Oncology Associates, PS
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists, P.C.
  - Vancouver, Washington, United States, 98686
    - Northwest Cancer Specialists, P.C.
- Wisconsin
  - Brookfield, Wisconsin, United States, 53045
    - Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital
  - Franklin, Wisconsin, United States, 53132
    - Wheaton Franciscan Healthcare - Reiman Cancer Center
  - Milwaukee, Wisconsin, United States, 53210
    - Wheaton Franciscan Healthcare - St. Joseph's Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - Wheaton Franciscan Healthcare - St. Francis Hospital
  - Wauwatosa, Wisconsin, United States, 53226
    - Wheaton Franciscan Healthcare -Wauwatosa Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men at least 18 years of age that have advanced prostate cancer that is treated with sipuleucel-T

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sipuleucel-T	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. Other Names: PROVENGE, APC8015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Further Quantify the Risk of Cerebrovascular Events Following Sipuleucel-T Therapy for All Subjects Time Frame: Every 3 months for a minimum of 3 years	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Time Frame: Every 3 months for a minimum of 3 years	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Investigators

Study Director: Bruce Brown, MD, Dendreon Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 27, 2011

Primary Completion (ACTUAL)

January 17, 2017

Study Completion (ACTUAL)

January 17, 2017

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

P10-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (ACTUAL)

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Prostatic Neoplasms

Clinical Trials on sipuleucel-T

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations