Phase II Study of ASP3550 in Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: ASP3550

• Registration Number: NCT00568516
• Lead Sponsor: Astellas Pharma Inc

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 273

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2.High dose group	ASP3550	-
1.Low dose group	ASP3550	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment	1 Year

Secondary Outcome Measures

Name	Time	Method
Changes in serum levels of testosterone, LH, FSH and PSA over time	1 Year
Proportion of patients with testosterone surge	1 Year
Time to the recurrence of serum PSA	1 Year
Percentage change in serum PSA	1 Year