Spots Global Cancer Trial Database for A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

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Trial Identification

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

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

Study ID: NCT01964170

Conditions

Prostate Cancer

Interventions

degarelix

Goserelin

Study Description

Brief 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.