Back to resultsPhase II Study of ASP3550 in Patients With Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP3550
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring ASP3550, Degarelix, Prostate cancer, Prostatic neoplasms
Eligibility Criteria
Inclusion Criteria:
- Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
- Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
- Has a serum testosterone level above 1.5 ng/mL at screening
- Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
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 preceding Screening Visit may be included
- Is being treated with a 5α-reductase inhibitor
- Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
- Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1.Low dose group
2.High dose group
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Secondary Outcome Measures
Proportion of patients with testosterone surge
Percentage change in serum PSA
Changes in serum levels of testosterone, LH, FSH and PSA over time
Time to the recurrence of serum PSA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568516
Brief Title
Phase II Study of ASP3550 in Patients With Prostate Cancer
Official Title
Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer
Detailed Description
Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was 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
ASP3550, Degarelix, Prostate cancer, Prostatic neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1.Low dose group
Arm Type
Experimental
Arm Title
2.High dose group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ASP3550
Other Intervention Name(s)
Degarelix
Intervention Description
subcutaneous administration
Primary Outcome Measure Information:
Title
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Proportion of patients with testosterone surge
Time Frame
1 Year
Title
Percentage change in serum PSA
Time Frame
1 Year
Title
Changes in serum levels of testosterone, LH, FSH and PSA over time
Time Frame
1 Year
Title
Time to the recurrence of serum PSA
Time Frame
1 Year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
Has a serum testosterone level above 1.5 ng/mL at screening
Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2
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 preceding Screening Visit may be included
Is being treated with a 5α-reductase inhibitor
Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
Kanto
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
City
Tohoku
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140631 in the JapicCTI-RNo. field
Learn more about this trial
Phase II Study of ASP3550 in Patients With Prostate Cancer
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