A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

Study Overview
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Brief Summary
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To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.

Detailed Description
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This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer. The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.

Official Title
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ASP3550 Phase III Study - An Open-Label, Active-Controlled, Parallel-Arm Study, Comparing ASP3550 With Goserelin Acetate in Patients With Prostate Cancer -

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: degarelix
* Drug: Goserelin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patient with histologically confirmed prostate cancer (adenocarcinoma). Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included. Has a serum testosterone level above 2.2 ng/mL at screening. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening. Has a serum PSA ≥ 2 ng/mL at screening. Has a life expectancy of at least 12 months. Exclusion Criteria: Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors. Received a 5α-reductase inhibitor within 25 weeks preceding screening. Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months. Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema. Has hypersensitivity towards mannitol. Has a marked prolongation of QT/QTc interval (two consecutive increases to >450 ms in QTc interval at retest) at screening. Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.

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: ASP3550 PART 1 and PART 2<br>Part 1 for 1 year treatment and Part 2 for an extended period of treatment | Drug: degarelix<br>* subcutaneous<br>* Other names: ASP3550;|
| Active Comparator: Goserelin<br>part 1 for 1 year treatment | Drug: Goserelin<br>* subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative castration rate of treatment in terms of serum testosterone level |  | Up to one year of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of castrated subjects in terms of serum testosterone level |  | Up to one year of the treatment | 
| Proportion of castrated subjects in terms of serum testosterone level |  | Baseline and Days 3, 7, and 28 | 
| Changes in serum levels of prostate-specific antigen (PSA) over time |  | Up to one year of the treatment | 
| Safety assessed by the incidence of adverse events |  | up to the end of treatment. approximately for 2 years | 

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