Prostate CancerPhase 2NCT00050297
YM598 in Patients With Rising PSA After Initial Therapy for Localized Prostate Cancer
A Phase 2 study testing YM598 in people with Prostate Cancer, run by Astellas Pharma Inc at 23 sites in 7 countries.
Trial summary
The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- YM598
- How many people
- Not given
- Where
- 23 sitesin 7 countries
- Study dates
- Start not givento Feb 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
23 sites in 7 countries.
23 sites in 7 countries
Poland5 sites
Regional Hospital, Department of Urology
Bydgoszcz
MedSource Poland
Gdansk
Bielanski Hospital, Department of Urology
Warsaw
Oncology Center, Department of Urinary Tract Cancer
Warsaw
Medical University, Clinic of Urology
Wroclaw
Czechia4 sites
Private Urology Out-patient Ward
Jablonec nad Nisou
Clinic of Urology, University Hospital
Králové
Clinic of Urology, University Hospital
Olomouc
Clinic of Urology, University Hospital
Prague
Germany4 sites
Haingasse 22
Bad Homburg, 61348
Klinik und Poliklinik für Urologie, Universitätsklinikum Carl-Gustav-Carus
Dresden
Klinik u. Poliklinik für Urologie, Philipps Universität, Baldingerstraße
Marburg
Krummbogen 15
Marburg
United Kingdom4 sites
Department of Urology, Bristol Royal Infirmary
Bristol
Department of Urology, Gartnavel Hospital
Glasgow
Department of Urology, Norfolk & Norwich Hospital
Norwich
Department of Urology, Taunton & Somerset Hospital
Taunton
Spain3 sites
Complejo Hospitaliaro Juan Canalejo, Servicio de Urología
Corunna
Fundacion Hospital Alcorcón, Servicio Urología
Madrid
Hospital Universitario Principe de Asturias, Servicio de Urología, Ctra.
Madrid
Belgium2 sites
University Clinic AZ
Brussels
University Clinic UCL St. Luc
Brussels
About this study
The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- YM598
- 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 posted4 Dec 2002 (estimated)
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- NCT00050297
- Sponsor's protocol ID
- 598-CL-004
- Status last verified
- Jun 2012
- First submitted
- 3 Dec 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 in Patients With Rising PSA After Initial Therapy for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT00050297
- Acronym / sponsor ID
- 598-CL-004
- Conditions
- 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
- Feb 2004 (actual)
- First posted
- 4 Dec 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 the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.
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.
23 sites in 7 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 Prostate Cancer, run by Astellas Pharma Inc at 23 sites in 7 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 23 sites in Poland, Czechia, Germany, United Kingdom, Spain and 2 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.