AzTrials
AzTrials

Advanced Prostate CancerPROCEEDNCT01306890

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

An observational study of Advanced Prostate Cancer and Prostatic Neoplasms, run by Dendreon at 333 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Advanced Prostate Cancer, Prostatic Neoplasms
What is being tested?
sipuleucel-T
How many people
1,976 participants
Where
333 sitesUnited States
Study dates
27 Jan 2011to 17 Jan 2017
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

333 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hendrick Medical Center / Hendrick Cancer Center

    Abilene, Texas, 79601

  • Texas Oncology-Abilene

    Abilene, Texas, 79606-5208

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • New Mexico Oncology Hematology Consultants, LTD

    Albuquerque, New Mexico, 87109

  • Georgia Cancer Specialists - Alpharetta

    Alpharetta, Georgia, 30005

  • Cancer Centers of Southwest Oklahoma

    Altus, Oklahoma, 73521

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Asheville Hematology & Oncology

    Asheville, North Carolina, 28803

  • Georgia Cancer Specialists - Athens

    Athens, Georgia, 30606

  • Georgia Cancer Specialists - Emory Midtown

    Atlanta, Georgia, 30308

  • Midtown Urology

    Atlanta, Georgia, 30308

  • Atlanta Hematology Oncology Associates

    Atlanta, Georgia, 30309-1710

  • Peachtree Hematology-Oncology Consultants, PC

    Atlanta, Georgia, 30318

  • Piedmont West

    Atlanta, Georgia, 30318

  • Emory University Hospital, The Emory Clinic, Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Georgia Urology, PA

    Atlanta, Georgia, 30342

  • Augusta Oncology Associates, PC

    Augusta, Georgia, 30901

  • Rocky Mountain Cancer Centers

    Aurora, Colorado, 80012

  • Northwest Georgia Oncology Centers, P.C.

    Austell, Georgia, 30106

  • Texas Oncology - Austin Midtown

    Austin, Texas, 78705

  • Texas Oncolocy - South Austin

    Austin, Texas, 78745

  • Texas Oncology - Austin North

    Austin, Texas, 78758

  • Mount Sinai Comprehensive Cancer Center

    Aventura, Florida, 33180

  • Urologic Consultants of SE PA

    Bala-Cynwyd, Pennsylvania, 19004

  • Chesapeake Urology Research Associates

    Baltimore, Maryland, 21204

  • Family Cancer Center Foundation, Inc.

    Bartlett, Tennessee, 38133

  • Texas Oncology - Beaumont, Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702-1449

  • Birmingham Hematology and Oncology Associates, LLC

    Bessemer, Alabama, 35022

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35205

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35211

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35213

  • Birmingham Hematology and Oncology Associates, LLC

    Birmingham, Alabama, 35235

  • New Jersey Urology, LLC

    Bloomfield, New Jersey, 07003

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Steward Sr. Elizabeth's Medical Center of Boston Inc.

    Boston, Massachusetts, 02135

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80303

  • Manatee Medical Research Institute, LLC

    Bradenton, Florida, 34205

  • St. Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044

  • Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital

    Brookfield, Wisconsin, 53045

  • Henry Ford Medical Center - Woodhaven

    Brownstown, Michigan, 48183

  • Urology Health Specialists, LLC

    Bryn Mawr, Pennsylvania, 19010

  • The Jonah Center

    Buffalo, New York, 14215

  • Zale P. Bernstein, MD, PC

    Buffalo, New York, 14215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Minnesota Oncology Hematology, P.A.

    Burnsville, Minnesota, 55337

  • Northwest Georgia Oncology Centers, P.C.

    Carrollton, Georgia, 30117

  • Northwest Georgia Oncology Centers, P.C.

    Cartersville, Georgia, 30121

  • Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina

    Cary, North Carolina, 27518

  • Texas Oncology - Cedar Park

    Cedar Park, Texas, 78613

  • Physician's Clinic of Iowa, P.C.

    Cedar Rapids, Iowa, 52401

  • Ironwood Cancer and Research

    Chandler, Arizona, 85224-5665

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • Presbyterian Hospital Cancer Center

    Charlotte, North Carolina, 28204

  • St. Louis Cancer Care, LLP

    Chesterfield, Missouri, 63017

  • South County Hematology/Oncology

    Chula Vista, California, 91911

  • TriState Urologic Services PSC, Inc. dba TUG Research

    Cincinnati, Ohio, 45212

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80909

  • Ellis Fischel Cancer Center - University of Missouri Health Care

    Columbia, Missouri, 65203

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1280

  • Minnesota Oncology Hematology, P.A.

    Coon Rapids, Minnesota, 55433

  • Wilshire Oncology Medical Group, Inc.

    Corona, California, 92879

  • Cancer Specialists of South Texas, PA

    Corpus Christi, Texas, 78412

  • Heartland Oncology & Hematology, PLLC

    Council Bluffs, Iowa, 51503

  • 21st Century Oncology

    Crestview, Florida, 32539

  • Louisiana Oncology Associates

    Crowley, Louisiana, 70526

  • Urology Clinics of North Texas, PLLC

    Dallas, Texas, 75231-4482

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Medical Center - Fairlane

    Dearborn, Michigan, 48126

  • Georgia Cancer Specialists - Stemmer

    Decatur, Georgia, 30033

  • Texas Oncology - Denton South

    Denton, Texas, 76210

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

  • Oncology and Hematology Specialists, P.A.

    Denville, New Jersey, 07830

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northwest Georgia Oncology Centers, P.C.

    Douglasville, Georgia, 30134

  • Gwinnett Hospital System Inc. dba Center for Cancer Care

    Duluth, Georgia, 30096

  • Cancer Centers of Southwest Oklahoma

    Duncan, Oklahoma, 73533

  • Regional Cancer Care, P.A.

    Durham, North Carolina, 27704

  • Duke University Medical Center - Duke South Clinics

    Durham, North Carolina, 27710

  • North Shore Hematology/Oncology Associates

    East Setauket, New York, 11733

  • Minnesota Oncology Hematology, P.A.

    Edina, Minnesota, 55435-2150

  • Texas Oncology - El Paso Cancer Treatment Center Grandview

    El Paso, Texas, 79902

  • Texas Oncology - El Paso Cancer Treatment Center Gateway

    El Paso, Texas, 79915

  • Texas Oncology - El Paso Cancer Treatment Center Joe Battle

    El Paso, Texas, 79939

  • Elkhart Clinic

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46514

  • Urology Specialists of Southern California

    Encino, California, 91436-2140

  • The Regional Cancer Center

    Erie, Pennsylvania, 16505

  • Urological Associates, Inc.

    Evansville, Indiana, 47714

  • Karmanos Cancer Institute at Farmington Hills

    Farmington Hills, Michigan, 48334

  • Georgia Cancer Specialists - Fayetteville

    Fayetteville, Georgia, 30215

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28304

  • Integrated Community Oncology Network

    Fleming Island, Florida, 32003

  • 21st Century Oncology

    Fort Myers, Florida, 33907

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana, 46845

  • Texas Oncology - Fort Worth 12th Avenue

    Fort Worth, Texas, 76104

  • Texas Oncology - Southwest Fort Worth

    Fort Worth, Texas, 76132

  • Robert A. Moss, M.D., F.A.C.P., Inc

    Fountain Valley, California, 92708

  • Wheaton Franciscan Healthcare - Reiman Cancer Center

    Franklin, Wisconsin, 53132

  • Queens Medical Associates

    Fresh Meadows, New York, 11366

  • Minnesota Oncology Hematology, P.A.

    Fridley, Minnesota, 55432

  • Carolina Urology Partners

    Gastonia, North Carolina, 28054-3456

  • The Jones Clinic, PC

    Germantown, Tennessee, 38138

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Palo Verde Cancer Specialists

    Glendale, Arizona, 85304

  • Pacific Shores Medical Group

    Glendale, California, 91204

  • Wilshire Oncology Medical Group, Inc.

    Glendora, California, 91741

  • Western Oncology/Hematology Associates, PC

    Golden, Colorado, 80401

  • Weatern Regional Medical Center / Cancer Treatment Centers of America

    Goodyear, Arizona, 85338

  • Myron I Murdock MD LLC

    Greenbelt, Maryland, 20770

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89014

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89074

  • UTHealth Oncology, Memorial Hermann Cancer Center

    Houston, Texas, 77030

  • Memorial Hennann Hosptial - Southwest Cancer Center

    Houston, Texas, 77074

  • Florida Cancer Specialists, PL

    Hudson, Florida, 34667

  • Memorial Hennann Hospital - Northeast Cancer Center

    Humble, Texas, 77338

  • Presbyterian Hospital Huntersville

    Huntersville, North Carolina, 28078

  • Pacific Shores Medical Group

    Huntington Beach, California, 92648

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32204

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32207

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • Metropolitan Urology Clinical Research

    Jeffersonville, Indiana, 47130

  • Joliet Oncology-Hematology Associates, Ltd.

    Joliet, Illinois, 60435

  • Urological Surgeons of Illinois

    Kankakee, Illinois, 60901

  • Saint Luke's Cancer Institute, Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Texas Oncology - Kyle

    Kyle, Texas, 78640

  • UCSD Medical Center - La Jolla

    La Jolla, California, 92037

  • UCSD Moores Cancer Center

    La Jolla, California, 92093-0820

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Indiana University Health La Porte Hospital

    La Porte, Indiana, 46350

  • Wilshire Oncology Medical Group, Inc.

    La Verne, California, 91750

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70508

  • Watson Clinic LLP, Center for Cancer Care & Research, Clark & Daughtrey Medical Group, PA

    Lakeland, Florida, 33805

  • Rocky Mountain Cancer Centers

    Lakewood, Colorado, 80228

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Gwinnett Hospital System Inc. dba Center for Cancer Care

    Lawrenceville, Georgia, 30046

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756

  • Texas Oncology - Lewisville

    Lewisville, Texas, 75067

  • Nebraska Hematology-Oncology, PC

    Lincoln, Nebraska, 68506

  • Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • Southeast Nebraska Hematology & Oncology Consultants, PC / Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68516

  • Little Rock Hematology Oncology: A Division of CARTI

    Little Rock, Arkansas, 72205

  • Rocky Mountain Cancer Centers

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Rocky Mountain Cancer Centers

    Longmont, Colorado, 80501

  • Pacific Shores Medical Group

    Los Alamitos, California, 90720

  • UCLA Institute of Urologic Oncology, UCLA Medical Center

    Los Angeles, California, 90024

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Tower Urology

    Los Angeles, California, 90048

  • Jewish Hospital & St. Mary's Healthcare

    Louisville, Kentucky, 40245

  • Northwest Florida Hematology Oncology PA

    Lynn Haven, Florida, 32444

  • Georgia Cancer Specialists - Macon

    Macon, Georgia, 31217

  • Minnesota Oncology Hematology, P.A.

    Maplewood, Minnesota, 55109

  • Georgia Cancer Specialists - Kennestone

    Marietta, Georgia, 30060

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Urology Enterprises

    Marietta, Georgia, 30060

  • Prostate Oncology Speciality Inc.

    Marina del Rey, California, 90292

  • Matthews Hematology Oncology Associates

    Matthews, North Carolina, 28105

  • Presbyterian Hospital Matthews

    Matthews, North Carolina, 28105

  • Family Cancer Center Foundation, Inc.

    Memphis, Tennessee, 38119

  • Family Cancer Center Foundation, Inc.

    Memphis, Tennessee, 38120

  • The West Clinic

    Memphis, Tennessee, 38120

  • Advanced Medical Specialties

    Miami, Florida, 33143

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • SouthWest Urology

    Middleburg Heights, Ohio, 44130

  • Wheaton Franciscan Healthcare - St. Joseph's Hospital

    Milwaukee, Wisconsin, 53210

  • Wheaton Franciscan Healthcare - St. Francis Hospital

    Milwaukee, Wisconsin, 53215

  • Minnesota Oncology Hematology, P.A.

    Minneapolis, Minnesota, 55404

  • University Of Minnesota

    Minneapolis, Minnesota, 55455

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545

  • Lake Norman Hematology Oncology Specialists

    Mooresville, North Carolina, 28117

  • Hematology-Oncology Associates of Northern NJ, PA; Carol G. Simon Cancer Center

    Morristown, New Jersey, 07962

  • Delaware Valley Urology, LLC

    Mount Laurel, New Jersey, 08054

  • Tri Valley Urology Medical Group

    Murrieta, California, 92562

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • 21st Century Oncology

    Naples, Florida, 34102

  • Premier Oncology

    Naples, Florida, 34102

  • Tennessee Oncology, Centennial Medical Center

    Nashville, Tennessee, 37203

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • The Jones Clinic, PC

    New Albany, Mississippi, 38652

  • Coastal Carolina Health Care, PA, dba New Bern Cancer Care

    New Bern, North Carolina, 28562

  • Grove Hill Clinical Research, Grove Hill Medical Center, Urology Center of Grove Hill

    New Britain, Connecticut, 06052

  • Yale Urology

    New Haven, Connecticut, 06511

  • Louisiana Oncology Associates

    New Iberia, Louisiana, 70560

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Florida Cancer Specialists, PL

    New Port Richey, Florida, 34655

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • NYU Langone Medical Center

    New York, New York, 10016

  • Oncology Specialists, S.C.

    Niles, Illinois, 60714

  • Lakeland Hospital

    Niles, Michigan, 49120

  • Urology of Virginia / SMG

    Norfolk, Virginia, 23502

  • Mid-Illinois Hematology & Oncology Associates, LTD

    Normal, Illinois, 61761

  • Integrated Medical Professionals

    North Hills, New York, 11042

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360

  • Henry Ford Medical Center - Columbus Center

    Novi, Michigan, 48377

  • Ocala Oncology Center

    Ocala, Florida, 33471

  • North County Oncology Medical Group, Inc.

    Oceanside, California, 92056

  • MedStar Montgomery Medical Center

    Olney, Maryland, 20832

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • Urology Cancer Center & GU Research Network

    Omaha, Nebraska, 68130

  • Louisiana Oncology Associates

    Opelousas, Louisiana, 70570

  • Hematology-Oncology Medical Group of Orange County, Inc.

    Orange, California, 92868

  • Medical Oncology Care Associates (MOCA)

    Orange, California, 92868

  • The Center for Cancer Prevention and Treatment, St. Joseph Hospital

    Orange, California, 92868

  • Atlantic Urological Associates

    Orange City, Florida, 32763

  • Integrated Community Oncology Network

    Orange Park, Florida, 32073

  • Kansas City Urology Care

    Overland Park, Kansas, 66211

  • Family Cancer Center Foundation, Inc.

    Oxford, Mississippi, 38655

  • PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Integrated Community Oncology Network

    Palatka, Florida, 32177

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • Advanced Urology, PC

    Parker, Colorado, 80134

  • Rocky Mountain Cancer Centers

    Parker, Colorado, 80138

  • Wilshire Oncology Medical Group, Inc.

    Pasadena, California, 91105

  • Sacred Heart Medical Oncology Groupl

    Pensacola, Florida, 32504

  • UPMC Cancer Center / Hillman Cancer Centerl

    Pittsburgh, Pennsylvania, 15232

  • Michiana Hematology Oncology, P. C.

    Plymouth, Indiana, 46563

  • Wilshire Oncology Medical Group, Inc.

    Pomona, California, 91767

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97213-2982

  • Providence Cancer Center Oncology and Hematology Care

    Portland, Oregon, 97213

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97225

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Harrison Poulsbo Hematology & Oncology

    Poulsbo, Washington, 98370

  • Rocky Mountain Cancer Centers

    Pueblo, Colorado, 81008

  • Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina

    Raleigh, North Carolina, 27607

  • Raleigh Hematology Oncology Associates, D.B.A., Cancer Centers of North Carolina

    Raleigh, North Carolina, 27614

  • Wilshire Oncology Medical Group, Inc.

    Rancho Cucamonga, California, 91730

  • Hubert H. Humphrey Cancer Center

    Robbinsdale, Minnesota, 55422

  • James P. Wilmot Cancer Center

    Rochester, New York, 14642

  • Harbin Clinic

    Rome, Georgia, 30165

  • Sutter Roseville Medical Center

    Roseville, California, 95677

  • Texas Oncology - Seton-Williamson

    Round Rock, Texas, 78665

  • Texas Oncology - Round Rock

    Round Rock, Texas, 78681

  • Sutter Cancer Center / Sacramento Center for Hematology and Medical Oncology

    Sacramento, California, 95816

  • Sutter Memorial Hospital

    Sacramento, California, 95819-3223

  • Integrated Community Oncology Network

    Saint Augustine, Florida, 32086

  • Michgan Institute of Urology, PC

    Saint Clair Shores, Michigan, 48081

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085-2158

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Minnesota Oncology Hematology, P.A.

    Saint Paul, Minnesota, 55102-2389

  • Huntsman Cancer Hospital

    Salt Lake City, Utah, 84112

  • Urology San Antonio Research

    San Antonio, Texas, 78229

  • Oncology San Antonio Research, LLC

    San Antonio, Texas, 78240

  • UCSD Medical Center - Hillcrest

    San Diego, California, 92103

  • Genesis Research

    San Diego, California, 92123

  • Medical Oncology Associates

    San Diego, California, 92123

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • Texas Oncology - San Marcos

    San Marcos, Texas, 78666

  • Georgia Cancer Specialists - Northside

    Sandy Springs, Georgia, 30342

  • Edward Alexson, MD, Inc.

    Santa Ana, California, 92705

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Adult and Pediatric Urology

    Sartell, Minnesota, 56377

  • 21st Century Oncology

    Scottsdale, Arizona, 85251

  • Pinnacle Oncology Hematology, Oncology Research Associates, PLLC

    Scottsdale, Arizona, 85258

  • Scranton Hematology Oncology

    Scranton, Pennsylvania, 18510

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington

    Seattle, Washington, 98109

  • Northwest Louisiana Oncology Associates Of Highland Clinic

    Shreveport, Louisiana, 71105

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Avera Cancer Institute, Avera Medical Group Oncology and Hematology

    Sioux Falls, South Dakota, 57105

  • Gwinnett Hospital System Inc. dba Center for Cancer Care

    Snellville, Georgia, 30078

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium, Michiana Hematology Oncology, P.C.

    South Bend, Indiana, 46601

  • Family Cancer Center Foundation, Inc.

    Southaven, Mississippi, 38671

  • Sparta Cancer Center

    Sparta, New Jersey, 07871

  • Urology Center of Spartanburg

    Spartanburg, South Carolina, 29303

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Oregon Urology Institute

    Springfield, Oregon, 97477

  • St. Louis Cancer Care, LLP

    St Louis, Missouri, 63127

  • Comprehensive Cancer Care

    St Louis, Missouri, 63141

  • The Stamford Hospital

    Stamford, Connecticut, 06902

  • Staten Island Urological Research, PC

    Staten Island, New York, 10304

  • Georgia Cancer Specialists - Stockbridge

    Stockbridge, Georgia, 30281

  • Stockton Hematology Oncology Medical Group

    Stockton, California, 95204

  • Associated Medical Professionals of New York, PLLC

    Syracuse, New York, 13210

Other trials in United States

About this study

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.

Read the 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.

Being tested
sipuleucel-T
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sipuleucel-TBiological

    Also called PROVENGE, APC8015

    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.

Study groups in NCT01306890
Study groupRoleWhat they receive
sipuleucel-TNot described
Receives: Biological: sipuleucel-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Every 3 months for a minimum of 3 years

Secondary outcomes (1)

  1. Survival

    To quantify survival by estimating the median time of survival in all subjects using the Kaplan-Meier method.

    Measured: Every 3 months for a minimum of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2011 (estimated)
  2. Study start27 Jan 2011
  3. Primary completion17 Jan 2017
  4. Study completion17 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,976 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01306890
Sponsor's protocol ID
P10-3
Acronym
PROCEED
Status last verified
Mar 2019
First submitted
28 Feb 2011
Last updated
7 Jun 2019
Data monitoring committee
No

Publications

  • Wei XX, Kwak L, Hamid A, He M, Sweeney C, Flanders SC, Harmon M, Choudhury AD. Outcomes in men with metastatic castration-resistant prostate cancer who received sipuleucel-T and no immediate subsequent therapy: experience at Dana Farber and in the PROCEED Registry. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):314-319. doi: 10.1038/s41391-022-00493-x. Epub 2022 Feb 10.

    PubMed 35145218

  • Sartor O, Armstrong AJ, Ahaghotu C, McLeod DG, Cooperberg MR, Penson DF, Kantoff PW, Vogelzang NJ, Hussain A, Pieczonka CM, Shore ND, Quinn DI, Small EJ, Heath EI, Tutrone RF, Schellhammer PF, Harmon M, Chang NN, Sheikh NA, Brown B, Freedland SJ, Higano CS. Survival of African-American and Caucasian men after sipuleucel-T immunotherapy: outcomes from the PROCEED registry. Prostate Cancer Prostatic Dis. 2020 Sep;23(3):517-526. doi: 10.1038/s41391-020-0213-7. Epub 2020 Feb 28.

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Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Prostate Cancer and Prostatic Neoplasms, run by Dendreon at 333 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 333 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01306890, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.

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