Study to Find Maintenance Dose for Periodic Administration of ASP3550
ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
1 other identifier
interventional
155
1 country
8
Brief Summary
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 12, 2010
CompletedFirst Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2012
CompletedOctober 31, 2024
October 1, 2024
1.5 years
December 1, 2010
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Baseline and for one year
Secondary Outcomes (6)
Changes in serum level of testosterone over time
Baseline and for one year
Changes in serum level of Luteinizing Hormone (LH) over time
Baseline and for one year
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Baseline and for one year
Changes in serum level of Prostate Specific Antigen (PSA) over time
Baseline and for one year
Time to the recurrence of serum PSA
For one year
- +1 more secondary outcomes
Study Arms (2)
High dose group
EXPERIMENTALASP3350 high dose
Low dose group
EXPERIMENTALASP3350 low dose
Interventions
Eligibility Criteria
You may qualify if:
- Histologically proven prostate cancer (adenocarcinoma) of all stages
- 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
You may not qualify if:
- Previous or present endocrine treatment for prostate cancer.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyusyu, Japan
Unknown Facility
Shuku, Japan
Unknown Facility
Tōhoku, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 16, 2010
Study Start
October 12, 2010
Primary Completion
April 24, 2012
Study Completion
April 24, 2012
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.