Study to Find Maintenance Dose for Periodic Administration of ASP3550

Phase 2

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: degarelix

• Registration Number: NCT01261572
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2010-10-12
• Study First Submitted: 2010-12-01
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Primary Completion: 2012-04-24
• Study Completion: 2012-04-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose group	degarelix	ASP3350 high dose
Low dose group	degarelix	ASP3350 low dose

Primary Outcome Measures

Name	Time	Method
Change in proportion of patients with serum testosterone ≤0.5 ng/mL over time	Baseline and for one year

Secondary Outcome Measures

Name	Time	Method
Time to the recurrence of serum PSA	For one year
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
Safety evaluated by the incidence of Adverse Events (AEs), physical exam and results of lab tests	One year