Study to Find Maintenance Dose for Periodic Administration of ASP3550
NCT ID: NCT01261572
Last Updated: 2024-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
155 participants
INTERVENTIONAL
2010-10-12
2012-04-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High dose group
ASP3350 high dose
degarelix
periodic injection
Low dose group
ASP3350 low dose
degarelix
periodic injection
Interventions
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degarelix
periodic injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention
* Serum testosterone level above 2.2 ng/mL
* An ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
* Serum PSA level above 2 ng/mL
Exclusion Criteria
However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months
* Treated with a 5α-reductase inhibitor
* A candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
* Concurrent or a history of severe liver disease
* Abnormal ECG such as long QTc
* A patient receiving ASP3550 in past times
* Administered drug in another clinical study or a post-market clinical study in the 28 days prior to the study
20 Years
MALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Chugoku, , Japan
Chūbu, , Japan
Hokkaido, , Japan
Kansai, , Japan
Kantou, , Japan
Kyusyu, , Japan
Shuku, , Japan
Tōhoku, , Japan
Countries
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Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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3550-CL-0009
Identifier Type: -
Identifier Source: org_study_id
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