Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen
A Multi-National Phase III Study of Satraplatin Plus Prednisone or Placebo Plus Prednisone in Patients With Hormone Refractory Prostate Cancer Previously Treated With One Cytotoxic Chemotherapy Regimen
1 other identifier
interventional
N/A
15 countries
211
Brief Summary
PURPOSE: The SPARC trial is designed to compare the combination of the investigational oral cytotoxic drug, satraplatin, and prednisone, versus prednisone alone as second line chemotherapy in patients with hormone-refractory prostate cancer (HRPC). TARGET PATIENT POPULATION: The SPARC trial is intended for patients who have hormone-refractory prostate cancer (HRPC) and whose disease has progressed after treatment with one chemotherapy regimen. Please refer to the Eligibility Criteria page for the key inclusion and exclusion criteria. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally. Satraplatin is also the only platinum-based drug that has demonstrated efficacy against prostate cancer in a randomized trial. RATIONALE: There are currently no approved chemotherapy drugs for the second line treatment of hormone-refractory prostate cancer (HRPC). In a preliminary randomized trial conducted in Europe, the combination of satraplatin and prednisone had superior activity compared to prednisone alone, for the treatment of HRPC patients who had not previously been treated with chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2003
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 30, 2003
CompletedFirst Posted
Study publicly available on registry
October 6, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedAugust 7, 2012
August 1, 2012
2.3 years
September 30, 2003
August 1, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Stage D2 metastatic prostate cancer
- Progression after one prior chemotherapy
- ECOG Performance status equal / less than 2
- Life expectancy \> 3 months
- Surgical or medical castration
- Adequate bone marrow, hepatic and renal functions
- Informed consent
You may not qualify if:
- More than one prior chemotherapy
- Prior platinum containing compounds
- Prior malignancy
- Prior significant RT/radionuclide therapy
- Major GI surgery or GI disease affecting absorption
- Disease with contraindication to steroids
- Brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agennixlead
Study Sites (211)
Birmingham Hematology and Oncology
Birmingham, Alabama, 35205, United States
Birmingham Hematology and Oncology
Birmingham, Alabama, 35235, United States
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Northern AZ Hematology & Oncology Assoc.
Sedona, Arizona, 86336, United States
Hematology Oncology Physicians/SMO
Tucson, Arizona, 85712, United States
Arizona Cancer Center
Tuscon, Arizona, 85724, United States
California Cancer Center
Fresno, California, 93720, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
Division of Hematology - Oncology
Los Angeles, California, 90095-7187, United States
University of California Davis Cancer Center, Division of Hematology-Oncology
Sacramento, California, 95817, United States
Sharp Healthcare - Clinical Oncology Research
San Diego, California, 92123, United States
Rocky Mountain Cancer Center - Midtown
Denver, Colorado, 80218, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
DeQuattro Community Cancer Center
Manchester, Connecticut, 06040, United States
Cancer Centers of Florida-Altamonte
Altamonte Springs, Florida, 34761, United States
The Center for Hematology Oncology
Boca Raton, Florida, 33486, United States
Hematology/Oncology Group of South Florida
Miami, Florida, 33176, United States
Innovative Medical Research of South Florida
Miami Shores, Florida, 33179, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
South Florida Oncology & Hematology
Plantation, Florida, 33324, United States
Hematology/Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Oncology and Hematology Associates of West Broward P.A.
Tamarac, Florida, 33321, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Northwest Medical Specialists
Niles, Illinois, 60714, United States
North Shore Research Association
Skokie, Illinois, 60076, United States
Central Indiana Cancer Centers
Fishers, Indiana, 46227, United States
Indiana Hematology Oncology Consultants
Indianapolis, Indiana, 46202, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, 52403, United States
Kansas City Cancer Centers - Southwest
Overland Park, Kansas, 66210, United States
Louisiana Oncology Associates
Lafayette, Louisiana, 70506, United States
LSU Health Science Center, Stanley S. Scott Cancer Center
New Orleans, Louisiana, 70112, United States
Maine Center for Cancer Medicine & Blood Disorders
Scarborough, Maine, 04074, United States
Berkshire Hematology Oncology
Pittsfield, Massachusetts, 01201, United States
Karmanos Cancer Institute, Wayne State University
Detroit, Michigan, 48201, United States
Maplewood Cancer Center
Maplewood, Minnesota, 55404, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, 65109, United States
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507, United States
Hematology/Oncology Consultants, Inc.
St Louis, Missouri, 63136, United States
Arch Medical Services, Inc.
Washington, Missouri, 63090, United States
Nebraska Methodist Hospital Cancer Center
Omaha, Nebraska, 68114, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
New Hampshire Oncology-Hematology PA
Hooksett, New Hampshire, 03106, United States
Hematology Oncology Associates
Albuquerque, New Mexico, 87106, United States
Lovelace Sandia Health Systems
Albuquerque, New Mexico, 87108, United States
Veterans Affairs Medical Center
Albuquerque, New Mexico, 87108, United States
The University of New Mexico
Albuquerque, New Mexico, 87131-0001, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
Albany Regional Cancer Center
Albany, New York, 12208, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
Advanced Oncology Associates
Armonk, New York, 10504, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Interlakes Oncology Hematology
Canandaigua, New York, 14623, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
New York Oncology Hematology
Rexford, New York, 12148, United States
VA Medical Center Syracuse
Syracuse, New York, 13210, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
Piedmont Hematology - Oncology
Winston-Salem, North Carolina, 27103, United States
Dayton Oncology Hematology
Kettering, Ohio, 45067, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Hematology and Oncology Associates of Northeastern PA / PC
Dunmore, Pennsylvania, 18512, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute- Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Cancer Center of the Carolinas, Seneca
Seneca, South Carolina, 29672, United States
The West Clinic
Memphis, Tennessee, 38120, United States
Texas Cancer Center
Abilene, Texas, 79606, United States
Texas Oncology
Arlington, Texas, 76012, United States
Southwest Regional Cancer Center
Austin, Texas, 78705, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Onoclogy PA - Bedford
Bedford, Texas, 76022, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230, United States
Texas Oncology, P.A.
Dallas, Texas, 75231-1449, United States
The Texas Cancer Center
Dallas, Texas, 75237, United States
TOPA Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Cancer Center
Denton, Texas, 76210, United States
El Paso Cancer Treatment Center
El Paso, Texas, 79915, United States
Texas Oncology, P.A.
Fort Worth, Texas, 76104, United States
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, 78624, United States
Texas Oncology, P.A.
Garland, Texas, 75042, United States
Texas Oncology, P.A. - Irving
Irving, Texas, 75601, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Longview Cancer Center
Longview, Texas, 75601, United States
S. Texas Cancer Center
McAllen, Texas, 78503, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Waco Cancer Care Research Center
Waco, Texas, 76712, United States
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Virginia Oncology Associates
Norfolk, Virginia, 23501, United States
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, 24153, United States
Puget Sound Cancer Center - Edmonds
Edmonds, Washington, 98026, United States
Cancer Care Northwest-North
Spokane, Washington, 99218, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano de Buenos Aires
Capital Federal, Buenos Aires, C1181ACH, Argentina
Clinica Oncologica de Excelencia
Capital Federal, Buenos Aires, C1405CBA, Argentina
Policlinica Bancaria "9 de Julio" Av. Gaona 2197
Capital Federal, Buenos Aires, C1416DRJ, Argentina
Hospital General de Agudos E. Tornu
Capital Federal, Buenos Aires, C1427ARN, Argentina
Salisbury Investigaciones Clinicas del Grupo CER S.A.
Quilmes, Buenos Aires, B1878DVB, Argentina
Hospital Italiano Regional del Sur Dept. Oncology
Bahía Blanca, B8001HXM, Argentina
Grupo Plaza Dept. Oncology
Belén de Escobar, B1625FWI, Argentina
Instituto Quirúrgico del Callao
Buenos Aires, C1022AAE, Argentina
Instituto Alexander Fleming
Buenos Aires, C1426ANZ, Argentina
Centro Oncológico LALCEC
Concepcion Del Uruguay, Entre Ríos, E3260FPB, Argentina
Hospital Italiano de Cordoba Dept. Oncology
Córdoba, X5004BAL, Argentina
Unidad Oncologica del Neuquen
Neuquén, Q8300HDH, Argentina
Caici Dept. Oncology
Rosario, S2000DSK, Argentina
Centro Oncologico Rosario
Rosario, S2000DSK, Argentina
Centro San Roque
San Miguel de Tucumán, Tucumán, T4000IAK, Argentina
Clinical Especializada ISIS
Santa Fe, S3000FFU, Argentina
AZ-VUB
Brussels, 1090, Belgium
Institut Jules Bordet Service de Chimiothérapie
Brussels, B-1000, Belgium
Hopital Erasme
Brussels, B-1070, Belgium
UCLC St. Luc
Brussels, B-1200, Belgium
Sint Maartenziekenhuis
Kortrijk, 8500, Belgium
Clinical Hospital Split Department of Oncology and Radiotherapy
Split, 21000, Croatia
Clinical Hostpital Rebro Department of Oncology
Zagreb, 10000, Croatia
Institut Bergonié
Bordeaux, 33076, France
Centre Georges François Leclerc
Dijon, 21079, France
Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie
Grenoble, 38043, France
Clinique du Mail Service d'Oncologie
Grenoble, 38100, France
Centre Hospitalier Départemental
La Roche-sur-Yon, 85025, France
CHU de Bicêtre
Le Kremlin-Bicêtre, 94278, France
Chu Dupuytren
Limoges, 87000, France
CRLC Léon Bérard
Lyon, 69373, France
Centre Hospitalier Belfort-Montbeliard
Montbéliard, 25209, France
CRLC Val d'Aurelle Paul-Lamarque
Montpellier, 34298, France
Centre Antoine Lacassagne Oncologie medicale
Nice, 06189, France
Hôpital Saint-Louis: Service de Radiotherapy
Paris, 75010, France
Hôpital Tenon
Paris, 75020, France
CHU de Poitiers
Poitiers, 86021, France
Institut Jean , Service d'Oncologie
Reims, 51100, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500, France
RWTH Aachen
Aachen, 52074, Germany
Vivantes Krankenhaus am Urban
Berlin, 10967, Germany
Fach- und Belegarzte fur Urologie
Berlin, 14197, Germany
Diakonissenkrankenhaus Dessau gGmbH
Dessau, 06846, Germany
Universitätsklinikum der Carl-Gustav-Carus Universität
Dresden, 01307, Germany
Stadtische Klinicen Frankfurt a.M. Hochst
Frankfurt a.M. Hochst, 65929, Germany
EuromedClinic
Fürth, 90763, Germany
Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg
Halle, 06120, Germany
Niedergelassener Urologe
Hamburg, 22399, Germany
Medizinische Hochschule
Hanover, 30625, Germany
Marienhospital II
Herne, 44627, Germany
Universitatklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Klinickum der Johannes-Gutenberg Universitat
Mainz, 55131, Germany
Klinikum der Philipps - Universitat Marburg
Marburg, 35043, Germany
Klinikum rechts der Isar
München, 81675, Germany
Universitatklinikum Munster
Münster, 48129, Germany
Klinik Bad Trissel
Oberaudorf, 83080, Germany
Urologische Praxis
Saarbrücken, 04416, Germany
St. Margit Hospital
Budapest, 1032, Hungary
St. Istvan Hospital
Budapest, 1096, Hungary
National Institute of Oncology
Budapest, 1122, Hungary
Pecs Medical University
Pécs, 7601, Hungary
Soroka Medical Center
Beerhseva, 84101, Israel
Rambam Medical Center
Haifa, 31096, Israel
Hadassah University
Jerusalem, 91120, Israel
Hospital Ein Kerem Asaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Istituto Nazionale per la Ricerca sul Cancro (IST)
Genoa, 16132, Italy
Universita degli Studi di Napoli Federico II-Nuovo Policlinico
Napoli, 80131, Italy
A.S.O. San Luigi
Orbassano, 10043, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
A.O. San Camillo-Forlanini
Rome, 00152, Italy
Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia
Rozanno (MI), 20089, Italy
Academic Hospital of the University of Amsterdam
Amsterdam, 1105 AZ, Netherlands
Academisch Ziekenhuis Nijmegen: Urology Department
Nijmegen, GA-6525, Netherlands
Streekziekenhuis Koningin : Dept. Urology
Winterswijk, 7101 BN, Netherlands
Essalud Dept. Oncology
Jesus Maria, 11, Peru
San Felipe (Oncomedical)
Lima, 11, Peru
INEN Dept Onco-Hemato
Lima, 34, Peru
Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny
Bialystok, 15-027, Poland
Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK
Gdynia, 81-519, Poland
Akademia Medyczna w Lodzi
Lodz, 93-509, Poland
Akademia Medyczna w Lublinie
Lublin, 20-954, Poland
Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut
Poznan, 61-866, Poland
Akademia Medyczna w Szczecinie
Szczecin, 70-111, Poland
Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut
Warsaw, 02-781, Poland
Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny
Wroclaw, 50-981, Poland
N.N Blokchin Cancer Research Centre
Moscow, 115478, Russia
Hertzen Research Institute of Oncology
Moscow, 125284, Russia
Medical Radilogical Research Center of Rams
Obninsk, 249036, Russia
Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica
Barcelona, 08025, Spain
Hospital Clinic i Provincial, Sevicio de Oncología Médica
Barcelona, 08036, Spain
Hospital Ramon y Cajal
Madrid, 20034, Spain
Hospital Clínico San Carlos, Sevicio de Oncología Médica
Madrid, 28040, Spain
Clinica Universitaria de Navarra, Sevicio de Oncología Médica
Pamplona, 31008, Spain
Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica
Santander, 39008, Spain
Instituto Valenciano de Oncología: Sevicio de Oncología Médica
Valencia, 46009, Spain
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
CRUK Institute for Cancer Studies
Birmingham, B152TT, United Kingdom
Bristol Oncology Centre
Bristol, BS2 8 ED, United Kingdom
Beatson Oncology Center
Glasgow, G11 6NT, United Kingdom
Guy's hospital
London, SE19RT, United Kingdom
St George's Healthcare Dept of Oncology, Tooting
London, SW17 0QT, United Kingdom
St. Bartholomew's Hospital Dept. of Medical Oncology
London, United Kingdom
Northern Centre for Cancer Treatment
Newcastle upon Tyne, NE4 6BE, United Kingdom
Lister Hospital Department of Urology
Stevenage Hertfordshire, SG1 4 AB, United Kingdom
Royal Marsden Hospital
Sutton, SM25PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2003
First Posted
October 6, 2003
Study Start
September 1, 2003
Primary Completion
January 1, 2006
Study Completion
March 1, 2007
Last Updated
August 7, 2012
Record last verified: 2012-08