YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy - Full Text View

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00048659

Purpose

The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

Condition	Intervention	Phase
Hormone-Refractory Prostate Cancer Prostatic Neoplasms	Drug: YM598	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048659

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Locations

United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States
United States, California
San Bernardino Urological Associates
San Bernardino, California, United States
Western Clinical Research, Inc.
Torrance, California, United States
United States, Florida
Shands Hospital
Gainesville, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
United States, Georgia
Georgia Urology,PA Research Institute
Atlanta, Georgia, United States
United States, Illinois
University of Illinois, Department of Urology
Chicago, Illinois, United States
University of Chicago, Section of Hematology/Oncology
Chicago, Illinois, United States
United States, Indiana
Michiana Hematology/Oncology
South Bend, Indiana, United States
United States, Louisiana
The Urologic Institute of New Orleans
Gretna, Louisiana, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States
United States, Tennessee
Memphis Cancer Center
Memphis, Tennessee, United States
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States
Australia
Southern Medical Day Care Centre
Wollongong, Australia
Department of Medical Oncology, The Canberra Hospital
Canberra, Australia
Department of Medical Oncology, Concord Hospital Medical Centre
Concord, Australia
Department of Medical Oncology, Newcastle Mater Hospital
Waratah, Australia
Department of Clinical Oncology, Royal North Shore Hospital
St Leonards, Australia
Queen Elizabeth Hospital, Clinical Hematology & Oncology
Woodville, Australia
Cancer Care Centre, St. George Hospital
Sydney, Australia
Division of Oncology Ward, Royal Brisbane Hospital
Herston, Australia
Belgium
Cliniques Universitaires St-Luc, Service d'Urologie
Bruxelles, Belgium
Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie
Charleroi, Belgium
France
Service d' Urologie CHU, Hopital Bichat
Paris, France
Centre Paul Papin
Angers, France
Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot
Lyon, France
Service d'Urologie, Hôpital Henri Mondor
Creteil, France
Germany
Krankenhause am Urban, Urologie Dieffenfachstr
Berlin, Germany
Dept Urology University of Essen
Essen, Germany
Urologische Klinik der MHH
Hannover, Germany
Klinikum Mannheim Urology
Mannheim, Germany
Ireland
Mater Misericordiae Hospital
Dublin, Ireland
Netherlands
Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie
Utrecht, Netherlands
Poland
Klinika Chemioterapii AM
Lodz, Poland
Oddzial Chemioterapii
Krakow, Poland
Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie
Krakow, Poland
Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow
Tarnow, Poland
Szpital CSK WAMl, Klinika Okologii
Warsaw, Poland
Klinika Nowotworow Ukladu
Warszawa, Poland
Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii
Opole, Poland
Spain
Hospital Universitario Príncipe de Asturias, Servicio de Urología
Madrid, Spain
Hospital Universitario de Getafe, Servicio de Urologia, Crta
Getafe (Madrid), Spain
Hospital Clinic i Provincial, Servicio de Oncologia
Barcelona, Spain
Hospital General Vall d'Hebron, Servicio de Oncología
Barcelona, Spain
Instituto Valenciano de Oncologia, Servicio de Oncologia
Valencia, Spain
United Kingdom
St Richard's Hospital
West Sussex, United Kingdom
Royal Surrey County Hospital
Surrey, United Kingdom
Department of Urology, East Surrey Hospital
Surrey, United Kingdom
Department of Urological Research, Derriford Hospital
Devon, United Kingdom
Imperial College School of Medicine, Dept Cancer Medicine
London, United Kingdom
Department of Urology, St Bartholomew's Hospital
London, United Kingdom
Clinical Research Centre, St George's Hospital, Urology Division
London, United Kingdom

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

More Information

No publications provided

Study ID Numbers:	598-CL-008
Study First Received:	November 4, 2002
Last Updated:	March 31, 2006
ClinicalTrials.gov Identifier:	NCT00048659 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Androgen-independent prostate cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009