NCT05181800

FIRMAGON® Intensive Drug Monitoring

A Multi-center, Single-arm, Non-interventional Study to Describe the Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer in Need of Androgen Deprivation Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,454 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety profile of FIRMAGON® (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese participants with prostate cancer need androgen deprivation therapy \[ADT\] treated with FIRMAGON®). Study Design This study is a multi-center, single-arm, non-interventional, prospective study among Chinese participants with prostate cancer in need of ADT, receiving treatment with FIRMAGON®. This program provided the minimum 6 doses and maximum 12 doses of FIRMAGON® to enrolled participants during one-year follow-up. Participants who met the inclusion criteria would or were accepting at least 6 self-financed doses of treatment in a hospital. Participants should return to the hospital for medical assessment every three months. The prescription of 6 (3 doses × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-participant pharmacy will distribute FIRMAGON® to eligible participants (participants should bring the prescriptions and the last FIRMAGON® boxes to get other doses). All enrolled participants were followed up to collect safety information for one year from the 1st dose unless withdrawal of Informed Consent Form, discontinuation for 2 months, lost to follow-up, death, or termination due to other reasons, whichever came first.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Degarelix Cohort	Non-interventional

Timeline

• Start date: 2019-08-20
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-01-06
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

1 site across 1 country: China