Study to Find Maintenance Dose for Periodic Administration of ASP3550

Study Overview
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Brief Summary
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To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

Detailed Description
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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.

Official Title
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ASP3550 Phase II Study - A Maintenance-Dose-Finding Study of Three-Month Depot in Patients With Prostate Cancer -

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: degarelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose group<br>ASP3350 high dose | Drug: degarelix<br>* periodic injection<br>* Other names: ASP3550;|
| Experimental: Low dose group<br>ASP3350 low dose | Drug: degarelix<br>* periodic injection<br>* Other names: ASP3550;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time |  | Baseline and for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatic neoplasms, Degarelix, ASP3550, Prostate cancer