Phase II Study of ASP3550 in Patients With Prostate Cancer

Study Overview
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Brief Summary
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To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Detailed Description
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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.

Official Title
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Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: ASP3550


Participation Criteria
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Eligibility Criteria
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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

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: 1.Low dose group<br> | Drug: ASP3550<br>* subcutaneous administration<br>* Other names: Degarelix;|
| Experimental: 2.High dose group<br> | Drug: ASP3550<br>* subcutaneous administration<br>* Other names: Degarelix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with testosterone surge |  | 1 Year | 
| Percentage change in serum PSA |  | 1 Year | 
| Changes in serum levels of testosterone, LH, FSH and PSA over time |  | 1 Year | 
| Time to the recurrence of serum PSA |  | 1 Year | 

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