NCT01964170

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	degarelix	subcutaneous
DRUG	Goserelin	subcutaneous

Timeline

• Start date: 2013-08-13
• Primary completion: 2015-06-05
• Completion: 2016-08-08
• First posted: 2013-10-17
• Last updated: 2024-10-31

Locations

8 sites across 1 country: Japan