Back to resultsStudy to Find Maintenance Dose for Periodic Administration of ASP3550
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
degarelix
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High dose group
Low dose group
Arm Description
ASP3350 high dose
ASP3350 low dose
Outcomes
Primary Outcome Measures
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Secondary Outcome Measures
Changes in serum level of testosterone over time
Changes in serum level of Luteinizing Hormone (LH) over time
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Changes in serum level of Prostate Specific Antigen (PSA) over time
Time to the recurrence of serum PSA
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01261572
Brief Title
Study to Find Maintenance Dose for Periodic Administration of ASP3550
Official Title
ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 12, 2010 (Actual)
Primary Completion Date
April 24, 2012 (Actual)
Study Completion Date
April 24, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.
Detailed Description
ASP3550 is administered periodically to patients with prostate cancer. The primary efficacy variable is the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
155 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose group
Arm Type
Experimental
Arm Description
ASP3350 high dose
Arm Title
Low dose group
Arm Type
Experimental
Arm Description
ASP3350 low dose
Intervention Type
Drug
Intervention Name(s)
degarelix
Other Intervention Name(s)
ASP3550
Intervention Description
periodic injection
Primary Outcome Measure Information:
Title
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time
Time Frame
Baseline and for one year
Secondary Outcome Measure Information:
Title
Changes in serum level of testosterone over time
Time Frame
Baseline and for one year
Title
Changes in serum level of Luteinizing Hormone (LH) over time
Time Frame
Baseline and for one year
Title
Changes in serum level of Follicle Stimulating Hormone (FSH) over time
Time Frame
Baseline and for one year
Title
Changes in serum level of Prostate Specific Antigen (PSA) over time
Time Frame
Baseline and for one year
Title
Time to the recurrence of serum PSA
Time Frame
For one year
Title
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests
Time Frame
One year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Shiku
Country
Japan
City
Touhoku
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=311
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
Study to Find Maintenance Dose for Periodic Administration of ASP3550
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