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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181800
• Other study ID #: 000351
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2193
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis as prostate cancer and need ADT

• Decision made to prescribe FIRMAGON prior to enrollment

• Willingness and ability to provide written informed consent

• The patients are taking the marketed drug FIRMAGON

Exclusion Criteria:

• Not signed informed consent

• Any patients who is unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• FIRMAGON Cohort
Non-interventional

Locations

Country	Name	City	State
China	China Primary Healthcare Foundation	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with any adverse events (AEs)	An AE was defined as any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.	From the signing of the informed consent up to the end-of-trial (12 months)
Primary	Percentage of subjects with serious AEs	An SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or results in prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event or reaction.	From the signing of the informed consent up to the end-of-trial (12 months)