Back to resultsYM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
Primary Purpose
Hormone-Refractory Prostate Cancer, Prostatic Neoplasms
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM598
Sponsored by
About this trial
This is an interventional treatment trial for Hormone-Refractory Prostate Cancer focused on measuring Androgen-independent prostate cancer
Eligibility Criteria
Sites / Locations
- Alaska Clinical Research Center, LLC
- San Bernardino Urological Associates
- Western Clinical Research, Inc.
- Shands Hospital
- Sylvester Comprehensive Cancer Center
- Georgia Urology,PA Research Institute
- University of Chicago, Section of Hematology/Oncology
- University of Illinois, Department of Urology
- Michiana Hematology/Oncology
- The Urologic Institute of New Orleans
- Henry Ford Hospital
- Washington University School of Medicine
- Memphis Cancer Center
- Virginia Mason Medical Center
- Department of Medical Oncology, The Canberra Hospital
- Department of Medical Oncology, Concord Hospital Medical Centre
- Division of Oncology Ward, Royal Brisbane Hospital
- Department of Clinical Oncology, Royal North Shore Hospital
- Cancer Care Centre, St. George Hospital
- Department of Medical Oncology, Newcastle Mater Hospital
- Southern Medical Day Care Centre
- Queen Elizabeth Hospital, Clinical Hematology & Oncology
- Cliniques Universitaires St-Luc, Service d'Urologie
- Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie
- Centre Paul Papin
- Service d'Urologie, Hôpital Henri Mondor
- Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot
- Service d' Urologie CHU, Hopital Bichat
- Krankenhause am Urban, Urologie Dieffenfachstr
- Dept Urology University of Essen
- Urologische Klinik der MHH
- Klinikum Mannheim Urology
- Mater Misericordiae Hospital
- Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie
- Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie
- Oddzial Chemioterapii
- Klinika Chemioterapii AM
- Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii
- Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow
- Szpital CSK WAMl, Klinika Okologii
- Klinika Nowotworow Ukladu
- Hospital Clinic i Provincial, Servicio de Oncologia
- Hospital General Vall d'Hebron, Servicio de Oncología
- Hospital Universitario de Getafe, Servicio de Urologia, Crta
- Hospital Universitario Príncipe de Asturias, Servicio de Urología
- Instituto Valenciano de Oncologia, Servicio de Oncologia
- Department of Urological Research, Derriford Hospital
- Clinical Research Centre, St George's Hospital, Urology Division
- Department of Urology, St Bartholomew's Hospital
- Imperial College School of Medicine, Dept Cancer Medicine
- Department of Urology, East Surrey Hospital
- Royal Surrey County Hospital
- St Richard's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00048659
First Posted
November 4, 2002
Last Updated
June 6, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00048659
Brief Title
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone-Refractory Prostate Cancer, Prostatic Neoplasms
Keywords
Androgen-independent prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
YM598
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Facility Information:
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
Country
United States
Facility Name
Shands Hospital
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
Country
United States
Facility Name
Georgia Urology,PA Research Institute
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
University of Chicago, Section of Hematology/Oncology
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Illinois, Department of Urology
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Michiana Hematology/Oncology
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
The Urologic Institute of New Orleans
City
Gretna
State/Province
Louisiana
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Memphis Cancer Center
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Department of Medical Oncology, The Canberra Hospital
City
Canberra
Country
Australia
Facility Name
Department of Medical Oncology, Concord Hospital Medical Centre
City
Concord
Country
Australia
Facility Name
Division of Oncology Ward, Royal Brisbane Hospital
City
Herston
Country
Australia
Facility Name
Department of Clinical Oncology, Royal North Shore Hospital
City
St Leonards
Country
Australia
Facility Name
Cancer Care Centre, St. George Hospital
City
Sydney
Country
Australia
Facility Name
Department of Medical Oncology, Newcastle Mater Hospital
City
Waratah
Country
Australia
Facility Name
Southern Medical Day Care Centre
City
Wollongong
Country
Australia
Facility Name
Queen Elizabeth Hospital, Clinical Hematology & Oncology
City
Woodville
Country
Australia
Facility Name
Cliniques Universitaires St-Luc, Service d'Urologie
City
Bruxelles
Country
Belgium
Facility Name
Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie
City
Charleroi
Country
Belgium
Facility Name
Centre Paul Papin
City
Angers
Country
France
Facility Name
Service d'Urologie, Hôpital Henri Mondor
City
Creteil
Country
France
Facility Name
Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Service d' Urologie CHU, Hopital Bichat
City
Paris
Country
France
Facility Name
Krankenhause am Urban, Urologie Dieffenfachstr
City
Berlin
Country
Germany
Facility Name
Dept Urology University of Essen
City
Essen
Country
Germany
Facility Name
Urologische Klinik der MHH
City
Hannover
Country
Germany
Facility Name
Klinikum Mannheim Urology
City
Mannheim
Country
Germany
Facility Name
Mater Misericordiae Hospital
City
Dublin
Country
Ireland
Facility Name
Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie
City
Utrecht
Country
Netherlands
Facility Name
Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie
City
Krakow
Country
Poland
Facility Name
Oddzial Chemioterapii
City
Krakow
Country
Poland
Facility Name
Klinika Chemioterapii AM
City
Lodz
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii
City
Opole
Country
Poland
Facility Name
Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow
City
Tarnow
Country
Poland
Facility Name
Szpital CSK WAMl, Klinika Okologii
City
Warsaw
Country
Poland
Facility Name
Klinika Nowotworow Ukladu
City
Warszawa
Country
Poland
Facility Name
Hospital Clinic i Provincial, Servicio de Oncologia
City
Barcelona
Country
Spain
Facility Name
Hospital General Vall d'Hebron, Servicio de Oncología
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Getafe, Servicio de Urologia, Crta
City
Getafe (Madrid)
Country
Spain
Facility Name
Hospital Universitario Príncipe de Asturias, Servicio de Urología
City
Madrid
Country
Spain
Facility Name
Instituto Valenciano de Oncologia, Servicio de Oncologia
City
Valencia
Country
Spain
Facility Name
Department of Urological Research, Derriford Hospital
City
Devon
Country
United Kingdom
Facility Name
Clinical Research Centre, St George's Hospital, Urology Division
City
London
Country
United Kingdom
Facility Name
Department of Urology, St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
Imperial College School of Medicine, Dept Cancer Medicine
City
London
Country
United Kingdom
Facility Name
Department of Urology, East Surrey Hospital
City
Surrey
Country
United Kingdom
Facility Name
Royal Surrey County Hospital
City
Surrey
Country
United Kingdom
Facility Name
St Richard's Hospital
City
West Sussex
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
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