Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

512

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

Sipuleucel-T

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

BIOLOGICAL

APC-Placebo

Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Trial Locations (71)

10003

Beth Israel Cancer Center, New York

10016

New York University, New York

10029

Clinical Cancer Center, New York

Mount Sinai School of Medicine, New York

10304

Staten Island Urological Research, Staten Island

10532

New York Medical College, Hawthorne

11733

North Shore Hematology Oncology Associates, East Setauket

12208

Albany Regional Cancer Center, Albany

The Urological Institute of Northeastern New York, Albany

19010

Center for Urologic Care, Bryn Mawr

19107

Jefferson Medical College, Philadelphia

19713

Helen F. Graham Cancer Center, Newark

20057

Lombardi Cancer Center, Washington D.C.

20307

Walter Reid Army Medical Center, Washington D.C.

20770

Myron I Murdock MD LLC, Greenbelt

21204

Chesapeake Urology Associates, Baltimore

23502

Urology of Virginia, PC, Norfolk

23507

Urology of Virginia, PC, Norfolk

27705

Duke University Medical Center, Durham

28204

McKay Urology, Charlotte

29572

Grand Strand Urology, Myrtle Beach

30342

Georgia Urology, P.A., Atlanta

33133

Miami Cancer Center, Miami

33173

Urology Center of South Florida, Miami

34761

Cancer Centers of Florida, Ocoee

34952

Hematology/Oncology Associates of the Treasure Coast, Port Saint Lucie

44195

Cleveland Clinic Foundation, Cleveland

46202

Indiana University, Indianapolis

53215

St. Luke's Hospital Immunotherapy Program, Milwaukee

53792

University of Wisconsin, Madison, Madison

University of Wisconsin, Madison

55455

University of Minnesota, Minneapolis

55905

Mayo Clinic, Rochester

60068

Lutheran General Cancer Center, Park Ridge

60153

Loyola University, Maywood

60612

Rush University Medical Center, Chicago

60640

Midwest Prostate & Urology Health Center, Chicago

75246

Mary Crowley, Dallas

76104

Urology Associates of North Texas, Fort Worth

77030

Baylor College of Medicine, Houston

80220

Rocky Mountain Cancer Center, Denver

84132

University of Utah, Salt Lake City

89135

Nevada Cancer Institute, Las Vegas

92120

Kaiser Permanente Medical Group, San Diego

92123

Sharp HealthCare, San Diego

92354

LLUMC for Molecular Biology and Gene Therapy, Loma Linda

92653

South Orange County Urological, Laguna Hills

94115

UCSF Cancer Center, San Francisco

95816

Sutter Cancer Center, Sacramento

97213

EACRI, Portland

97477

Oregon Urology Specialists, Springfield

98101

Virginia Mason Medical Center, Seattle

98109

Seattle Cancer Care Alliance, Seattle

98801

Wenatchee Valley Medical Center, Wenatchee

99218

Cancer Care Northwest, Spokane

982262

Comprehensive Cancer Center, Palm Springs

90089-9178

USC Keck School of Medicine, Los Angeles

90095-1738

UCLA, Los Angeles

06052

Connecticut Urological Research at Grove Hill, New Britain

02115-6084

Dana-Farber Cancer Institute, Boston

01805

Lahey Clinic (Department of Urology), Burlington

07601

Hackensack University Medical Center, Hackensack

07052

Associates in Urology, LLC, West Orange

45267-0502

University of Cincinnati, Cincinnati

97227-1191

Kaiser Permanente Medical Group, Portland

V8T 5G1

Can-Med Medical Research, Inc., Victoria

N6A 4G5

London Health Sciences Centre, London

M1S 4V5

Urology CURC Scarborough, Scarborough Village

M4N 3M5

Sunnybrook & Women's College HSC, Toronto

M5G 2M9

Princess Margaret Hospital, Toronto

H2L 4M1

Hospital Notre Dame du CHUM, Montreal

Sponsors

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INDUSTRY