Hormone-Refractory Prostate CancerPhase 2NCT00048659
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
A Phase 2 study testing YM598 in people with Hormone-Refractory Prostate Cancer and Prostatic Neoplasms, run by Astellas Pharma Inc at 53 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hormone-Refractory Prostate Cancer, Prostatic Neoplasms
- What is being tested?
- YM598
- How many people
- Not given
- Where
- 53 sitesin 10 countries
- Study dates
- Start not givento Jun 2004
- Phase
- Phase 2
- 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
Trial locations and contacts
53 sites in 10 countries.
53 sites in 10 countries
United States14 sites
Alaska Clinical Research Center, LLC
Anchorage, Alaska
Georgia Urology,PA Research Institute
Atlanta, Georgia
University of Chicago, Section of Hematology/Oncology
Chicago, Illinois
University of Illinois, Department of Urology
Chicago, Illinois
Henry Ford Hospital
Detroit, Michigan
Shands Hospital
Gainesville, Florida
The Urologic Institute of New Orleans
Gretna, Louisiana
Memphis Cancer Center
Memphis, Tennessee
Sylvester Comprehensive Cancer Center
Miami, Florida
San Bernardino Urological Associates
San Bernardino, California
Virginia Mason Medical Center
Seattle, Washington
Michiana Hematology/Oncology
South Bend, Indiana
Washington University School of Medicine
St Louis, Missouri
Western Clinical Research, Inc.
Torrance, California
Australia8 sites
Department of Medical Oncology, The Canberra Hospital
Canberra
Department of Medical Oncology, Concord Hospital Medical Centre
Concord
Division of Oncology Ward, Royal Brisbane Hospital
Herston
Department of Clinical Oncology, Royal North Shore Hospital
St Leonards
Cancer Care Centre, St. George Hospital
Sydney
Department of Medical Oncology, Newcastle Mater Hospital
Waratah
Southern Medical Day Care Centre
Wollongong
Queen Elizabeth Hospital, Clinical Hematology & Oncology
Woodville
Poland7 sites
Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie
Krakow
Oddzial Chemioterapii
Krakow
Klinika Chemioterapii AM
Lodz
Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii
Opole
Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow
Tarnów
Klinika Nowotworow Ukladu
Warsaw
Szpital CSK WAMl, Klinika Okologii
Warsaw
United Kingdom7 sites
Department of Urological Research, Derriford Hospital
Devon
Clinical Research Centre, St George's Hospital, Urology Division
London
Department of Urology, St Bartholomew's Hospital
London
Imperial College School of Medicine, Dept Cancer Medicine
London
Department of Urology, East Surrey Hospital
Surrey
Royal Surrey County Hospital
Surrey
St Richard's Hospital
West Sussex
Spain5 sites
Hospital Clinic i Provincial, Servicio de Oncologia
Barcelona
Hospital General Vall d'Hebron, Servicio de Oncología
Barcelona
Hospital Universitario de Getafe, Servicio de Urologia, Crta
Getafe (Madrid)
Hospital Universitario Príncipe de Asturias, Servicio de Urología
Madrid
Instituto Valenciano de Oncologia, Servicio de Oncologia
Valencia
France4 sites
Centre Paul Papin
Angers
Service d'Urologie, Hôpital Henri Mondor
Créteil
Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot
Lyon
Service d' Urologie CHU, Hopital Bichat
Paris
Germany4 sites
Krankenhause am Urban, Urologie Dieffenfachstr
Berlin
Dept Urology University of Essen
Essen
Urologische Klinik der MHH
Hanover
Klinikum Mannheim Urology
Mannheim
Belgium2 sites
Cliniques Universitaires St-Luc, Service d'Urologie
Brussels
Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie
Charleroi
Netherlands1 site
Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie
Utrecht
About this study
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.
- Being tested
- YM598
- Keywords
- Androgen-independent prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YM598Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2002 (estimated)
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-Refractory Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00048659
- Sponsor's protocol ID
- 598-CL-008
- Status last verified
- Jun 2012
- First submitted
- 4 Nov 2002
- Last updated
- 7 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
- ClinicalTrials.gov ID
- NCT00048659
- Acronym / sponsor ID
- 598-CL-008
- Keywords
- Androgen-independent prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study completion
- Jun 2004 (actual)
- First posted
- 6 Nov 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YM598 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YM598 in people with Hormone-Refractory Prostate Cancer and Prostatic Neoplasms, run by Astellas Pharma Inc at 53 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Australia, Poland, United Kingdom, Spain and 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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?
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 Jun 2012.