AzTrials
AzTrials

Prostate CancerPhase 3NCT00069745

Satraplatin in Hormone Refractory Prostate Cancer Patients Previously Treated With One Cytotoxic Chemotherapy Regimen

A Phase 3 study testing Satraplatin and Prednisone in people with Prostate Cancer and Hormone Refractory Prostate Cancer, run by Agennix at 211 sites in 15 countries.

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

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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Satraplatin and Prednisone
How many people
Not given
Where
211 sitesin 15 countries
Study dates
Sep 2003to Mar 2007
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

211 sites in 15 countries.

211 sites in 15 countries

United States105 sites

  • Texas Cancer Center

    Abilene, Texas, 79606

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Hematology Oncology Associates

    Albuquerque, New Mexico, 87106

  • Lovelace Sandia Health Systems

    Albuquerque, New Mexico, 87108

  • Veterans Affairs Medical Center

    Albuquerque, New Mexico, 87108

  • The University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Cancer Centers of Florida-Altamonte

    Altamonte Springs, Florida, 34761

  • Texas Oncology

    Arlington, Texas, 76012

  • Advanced Oncology Associates

    Armonk, New York, 10504

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Texas Oncology Cancer Center

    Austin, Texas, 78731

  • Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Onoclogy PA - Bedford

    Bedford, Texas, 76022

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35205

  • Birmingham Hematology and Oncology

    Birmingham, Alabama, 35235

  • The Center for Hematology Oncology

    Boca Raton, Florida, 33486

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Interlakes Oncology Hematology

    Canandaigua, New York, 14623

  • Raleigh Hematology Oncology Clinic

    Cary, North Carolina, 27511

  • Oncology Associates of Cedar Rapids

    Cedar Rapids, Iowa, 52403

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • Texas Cancer Center at Medical City

    Dallas, Texas, 75230

  • Texas Oncology, P.A.

    Dallas, Texas, 75231-1449

  • The Texas Cancer Center

    Dallas, Texas, 75237

  • TOPA Sammons Cancer Center

    Dallas, Texas, 75246

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Texas Cancer Center

    Denton, Texas, 76210

  • Rocky Mountain Cancer Center - Midtown

    Denver, Colorado, 80218

  • Karmanos Cancer Institute, Wayne State University

    Detroit, Michigan, 48201

  • Hematology and Oncology Associates of Northeastern PA / PC

    Dunmore, Pennsylvania, 18512

  • Puget Sound Cancer Center - Edmonds

    Edmonds, Washington, 98026

  • El Paso Cancer Treatment Center

    El Paso, Texas, 79915

  • Willamette Valley Cancer Center

    Eugene, Oregon, 97401

  • Central Indiana Cancer Centers

    Fishers, Indiana, 46227

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • San Antonio Tumor & Blood Clinic

    Fredericksburg, Texas, 78624

  • California Cancer Center

    Fresno, California, 93720

  • Texas Oncology, P.A.

    Garland, Texas, 75042

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • New Hampshire Oncology-Hematology PA

    Hooksett, New Hampshire, 03106

  • Indiana Hematology Oncology Consultants

    Indianapolis, Indiana, 46202

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46227

  • Texas Oncology, P.A. - Irving

    Irving, Texas, 75601

  • Capitol Comprehensive Cancer Care Clinic

    Jefferson City, Missouri, 65109

  • Dayton Oncology Hematology

    Kettering, Ohio, 45067

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70506

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Lake Vista Cancer Center

    Lewisville, Texas, 75067

  • Pacific Shores Medical Group

    Long Beach, California, 90813

  • Longview Cancer Center

    Longview, Texas, 75601

  • Division of Hematology - Oncology

    Los Angeles, California, 90095-7187

  • DeQuattro Community Cancer Center

    Manchester, Connecticut, 06040

  • Maplewood Cancer Center

    Maplewood, Minnesota, 55404

  • S. Texas Cancer Center

    McAllen, Texas, 78503

  • The West Clinic

    Memphis, Tennessee, 38120

  • Texas Cancer Center of Mesquite

    Mesquite, Texas, 75150

  • Hematology/Oncology Group of South Florida

    Miami, Florida, 33176

  • Innovative Medical Research of South Florida

    Miami Shores, Florida, 33179

  • Allison Cancer Center

    Midland, Texas, 79701

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • LSU Health Science Center, Stanley S. Scott Cancer Center

    New Orleans, Louisiana, 70112

  • Florida Cancer Institute

    New Port Richey, Florida, 34655

  • Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Northwest Medical Specialists

    Niles, Illinois, 60714

  • Virginia Oncology Associates

    Norfolk, Virginia, 23501

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • West Texas Cancer Center

    Odessa, Texas, 79761

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 73120

  • Nebraska Methodist Hospital Cancer Center

    Omaha, Nebraska, 68114

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Hematology Oncology Associates

    Phoenix, Arizona, 85012

  • University of Pittsburgh Cancer Institute- Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Berkshire Hematology Oncology

    Pittsfield, Massachusetts, 01201

  • South Florida Oncology & Hematology

    Plantation, Florida, 33324

  • Hematology/Oncology Associates of Treasure Coast

    Port Saint Lucie, Florida, 34952

  • New York Oncology Hematology

    Rexford, New York, 12148

  • University of California Davis Cancer Center, Division of Hematology-Oncology

    Sacramento, California, 95817

  • St. Joseph Oncology, Inc.

    Saint Joseph, Missouri, 64507

  • Onc and Hem Associates of SW VA, Inc.

    Salem, Virginia, 24153

  • Hematology Oncology Associates of South Texas

    San Antonio, Texas, 78229

  • Sharp Healthcare - Clinical Oncology Research

    San Diego, California, 92123

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Maine Center for Cancer Medicine & Blood Disorders

    Scarborough, Maine, 04074

  • Northern AZ Hematology & Oncology Assoc.

    Sedona, Arizona, 86336

  • Cancer Center of the Carolinas, Seneca

    Seneca, South Carolina, 29672

  • North Shore Research Association

    Skokie, Illinois, 60076

  • Cancer Care Northwest-North

    Spokane, Washington, 99218

  • Hematology/Oncology Consultants, Inc.

    St Louis, Missouri, 63136

  • VA Medical Center Syracuse

    Syracuse, New York, 13210

  • Oncology and Hematology Associates of West Broward P.A.

    Tamarac, Florida, 33321

  • Hematology Oncology Physicians/SMO

    Tucson, Arizona, 85712

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Arizona Cancer Center

    Tuscon, Arizona, 85724

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684

  • Waco Cancer Care Research Center

    Waco, Texas, 76712

  • Arch Medical Services, Inc.

    Washington, Missouri, 63090

  • Texas Oncology, P.A. - Deke Slayton Cancer Center

    Webster, Texas, 77598

  • Piedmont Hematology - Oncology

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany18 sites

  • RWTH Aachen

    Aachen, 52074

  • Vivantes Krankenhaus am Urban

    Berlin, 10967

  • Fach- und Belegarzte fur Urologie

    Berlin, 14197

  • Diakonissenkrankenhaus Dessau gGmbH

    Dessau, 06846

  • Universitätsklinikum der Carl-Gustav-Carus Universität

    Dresden, 01307

  • Stadtische Klinicen Frankfurt a.M. Hochst

    Frankfurt a.M. Hochst, 65929

  • EuromedClinic

    Fürth, 90763

  • Klinikum der medizinischen Fakultät der Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120

  • Niedergelassener Urologe

    Hamburg, 22399

  • Medizinische Hochschule

    Hanover, 30625

  • Marienhospital II

    Herne, 44627

  • Universitatklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinickum der Johannes-Gutenberg Universitat

    Mainz, 55131

  • Klinikum der Philipps - Universitat Marburg

    Marburg, 35043

  • Klinikum rechts der Isar

    München, 81675

  • Universitatklinikum Munster

    Münster, 48129

  • Klinik Bad Trissel

    Oberaudorf, 83080

  • Urologische Praxis

    Saarbrücken, 04416

Other trials in Germany

France17 sites

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Georges François Leclerc

    Dijon, 21079

  • Hôpital de La Tronche - CHU de Grenoble: Departement de cacerologie et d'hematologie

    Grenoble, 38043

  • Clinique du Mail Service d'Oncologie

    Grenoble, 38100

  • Centre Hospitalier Départemental

    La Roche-sur-Yon, 85025

  • CHU de Bicêtre

    Le Kremlin-Bicêtre, 94278

  • Chu Dupuytren

    Limoges, 87000

  • CRLC Léon Bérard

    Lyon, 69373

  • Centre Hospitalier Belfort-Montbeliard

    Montbéliard, 25209

  • CRLC Val d'Aurelle Paul-Lamarque

    Montpellier, 34298

  • Centre Antoine Lacassagne Oncologie medicale

    Nice, 06189

  • Hôpital Saint-Louis: Service de Radiotherapy

    Paris, 75010

  • Hôpital Tenon

    Paris, 75020

  • CHU de Poitiers

    Poitiers, 86021

  • Institut Jean , Service d'Oncologie

    Reims, 51100

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Argentina16 sites

  • Hospital Italiano Regional del Sur Dept. Oncology

    Bahía Blanca, B8001HXM

  • Grupo Plaza Dept. Oncology

    Belen de Escobar, B1625FWI

  • Instituto Quirúrgico del Callao

    Buenos Aires, C1022AAE

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

  • Hospital Italiano de Buenos Aires

    Capital Federal, Buenos Aires, C1181ACH

  • Clinica Oncologica de Excelencia

    Capital Federal, Buenos Aires, C1405CBA

  • Policlinica Bancaria "9 de Julio" Av. Gaona 2197

    Capital Federal, Buenos Aires, C1416DRJ

  • Hospital General de Agudos E. Tornu

    Capital Federal, Buenos Aires, C1427ARN

  • Centro Oncológico LALCEC

    Concepcion Del Uruguay, Entre Ríos, E3260FPB

  • Hospital Italiano de Cordoba Dept. Oncology

    Córdoba, X5004BAL

  • Unidad Oncologica del Neuquen

    Neuquén, Q8300HDH

  • Salisbury Investigaciones Clinicas del Grupo CER S.A.

    Quilmes, Buenos Aires, B1878DVB

  • Caici Dept. Oncology

    Rosario, S2000DSK

  • Centro Oncologico Rosario

    Rosario, S2000DSK

  • Centro San Roque

    San Miguel de Tucumán, Tucumán, T4000IAK

  • Clinical Especializada ISIS

    Santa Fe, S3000FFU

Other trials in Argentina

United Kingdom10 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • CRUK Institute for Cancer Studies

    Birmingham, B152TT

  • Bristol Oncology Centre

    Bristol, BS2 8 ED

  • Beatson Oncology Center

    Glasgow, G11 6NT

  • Guy's hospital

    London, SE19RT

  • St George's Healthcare Dept of Oncology, Tooting

    London, SW17 0QT

  • St. Bartholomew's Hospital Dept. of Medical Oncology

    London

  • Northern Centre for Cancer Treatment

    Newcastle upon Tyne, NE4 6BE

  • Lister Hospital Department of Urology

    Stevenage Hertfordshire, SG1 4 AB

  • Royal Marsden Hospital

    Sutton, SM25PT

Other trials in United Kingdom

Poland8 sites

  • Oddzial Chemioterapii, Bialostocki Osrodek Onkologiczny

    Bialystok, 15-027

  • Oddzial Onkologii I Radioterapii, Szpital Morski im. PCK

    Gdynia, 81-519

  • Akademia Medyczna w Lodzi

    Lodz, 93-509

  • Akademia Medyczna w Lublinie

    Lublin, 20-954

  • Oddzial Radioterapii, Wielkopolskie Centrum Onkologii - Instytut

    Poznan, 61-866

  • Akademia Medyczna w Szczecinie

    Szczecin, 70-111

  • Klinika Nowotworow Ukladu Moczowego, Centrum Onkologii - Instytut

    Warsaw, 02-781

  • Oddzial Chemioterapii, 4 Wojskowy Szpital Kliniczny

    Wroclaw, 50-981

Other trials in Poland

Spain7 sites

  • Hospital de la Santa Creu i Sant Pau, Sevicio de Oncología Médica

    Barcelona, 08025

  • Hospital Clinic i Provincial, Sevicio de Oncología Médica

    Barcelona, 08036

  • Hospital Ramon y Cajal

    Madrid, 20034

  • Hospital Clínico San Carlos, Sevicio de Oncología Médica

    Madrid, 28040

  • Clinica Universitaria de Navarra, Sevicio de Oncología Médica

    Pamplona, 31008

  • Hospital Universitario Marqués de Valdecilla, Sevicio de Oncología Médica

    Santander, 39008

  • Instituto Valenciano de Oncología: Sevicio de Oncología Médica

    Valencia, 46009

Other trials in Spain

Italy6 sites

  • Istituto Nazionale per la Ricerca sul Cancro (IST)

    Genoa, 16132

  • Universita degli Studi di Napoli Federico II-Nuovo Policlinico

    Naples, 80131

  • A.S.O. San Luigi

    Orbassano, 10043

  • Azienda Ospedaliera di Padova

    Padova, 35128

  • A.O. San Camillo-Forlanini

    Rome, 00152

  • Istituto Clinico Humanitas: Dipartimento di Oncologia Medica ed Ematologia

    Rozanno (MI), 20089

Other trials in Italy

Belgium5 sites

  • AZ-VUB

    Brussels, 1090

  • Institut Jules Bordet Service de Chimiothérapie

    Brussels, B-1000

  • Hopital Erasme

    Brussels, B-1070

  • UCLC St. Luc

    Brussels, B-1200

  • Sint Maartenziekenhuis

    Kortrijk, 8500

Other trials in Belgium

Hungary4 sites

  • St. Margit Hospital

    Budapest, 1032

  • St. Istvan Hospital

    Budapest, 1096

  • National Institute of Oncology

    Budapest, 1122

  • Pecs Medical University

    Pécs, 7601

Other trials in Hungary

Israel4 sites

  • Soroka Medical Center

    Beerhseva, 84101

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University

    Jerusalem, 91120

  • Hospital Ein Kerem Asaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

Netherlands3 sites

  • Academic Hospital of the University of Amsterdam

    Amsterdam, 1105 AZ

  • Academisch Ziekenhuis Nijmegen: Urology Department

    Nijmegen, GA-6525

  • Streekziekenhuis Koningin : Dept. Urology

    Winterswijk, 7101 BN

Other trials in Netherlands

Peru3 sites

  • Essalud Dept. Oncology

    Jesus Maria, 11

  • San Felipe (Oncomedical)

    Lima, 11

  • INEN Dept Onco-Hemato

    Lima, 34

Other trials in Peru

Russia3 sites

  • N.N Blokchin Cancer Research Centre

    Moscow, 115478

  • Hertzen Research Institute of Oncology

    Moscow, 125284

  • Medical Radilogical Research Center of Rams

    Obninsk, 249036

Other trials in Russia

Croatia2 sites

  • Clinical Hospital Split Department of Oncology and Radiotherapy

    Split, 21000

  • Clinical Hostpital Rebro Department of Oncology

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: 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

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).

Read more

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

Being tested
Satraplatin, Prednisone
Keywords
Prostatic Neoplasms, Cancer Treatment Protocols, Antineoplastic protocols, One Prior Cytotoxic Chemotherapy Regimen
Medical subject headings
Prostatic Neoplasms

What participants receive

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

Timeline

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

  1. First posted6 Oct 2003 (estimated)
  2. Study startSep 2003
  3. Primary completionJan 2006
  4. Study completionMar 2007

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069745
Sponsor's protocol ID
GPC SAT3-03-01
Status last verified
Aug 2012
First submitted
30 Sep 2003
Last updated
7 Aug 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Satraplatin and Prednisone in people with Prostate Cancer and Hormone Refractory Prostate Cancer, run by Agennix at 211 sites in 15 countries.

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 7 inclusion and 7 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 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 211 sites in United States, Germany, France, Argentina, United Kingdom and 10 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00069745.

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 Aug 2012.

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