FIRMAGON Intensive Drug Monitoring Protocol

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

To evaluate the safety profile of FIRMAGON (to fulfill the regulatory authority's requirement of Intensive Drug Monitoring in Chinese patients 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 patients with prostate cancer and need ADT receiving treatment with FIRMAGON. This program will provide the minimum 6 doses and maximum 12 doses of FIRMAGON to enrolled patients during one-year follow-up. Patients who meet inclusion criteria and will or are accepting at least 6 self-financed doses treatment in hospital. Patients should return to the hospital for medical assessment every three months. The prescription of 6 (3 dose × 2 times) self-financed doses will be given by doctors after assessment, and the direct-to-patient pharmacy will distribute FIRMAGON to eligible patients (patients should bring the prescriptions and the last FIRMAGON boxes to get other doses). All enrolled patients will be 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 comes first.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05181800
• Study type: Observational
• Source: Ferring Pharmaceuticals
• Status: Completed
• Start date: September 1, 2019
• Completion date: December 31, 2022