Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Goserelin

Antineoplastic Agents, Hormonal

Part 1 for 1 year treatment and Part 2 for an extended period of treatment

degarelix

Medical Director

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

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.

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 -

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Astellas Pharma Inc

Use Central Contact

To find effective doses of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer	NCT01964170	Prostate Cancer	degarelix Goserelin	20 Years -	Astellas Pharma Inc
Study to Find Maintenance Dose for Periodic Administration of ASP3550	NCT01261572	Prostatic Neopl...	degarelix	20 Years -	Astellas Pharma Inc
A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer	NCT01964170	Prostate Cancer	degarelix Goserelin	20 Years -	Astellas Pharma Inc
Study to Find Maintenance Dose for Periodic Administration of ASP3550	NCT01261572	Prostatic Neopl...	degarelix	20 Years -	Astellas Pharma Inc

Spots Global Cancer Trial Database for asp3550

Every month we try and update this database with for asp3550 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for asp3550

Every month we try and update this database with for asp3550 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for asp3550 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.