FIRMAGON® Intensive Drug Monitoring

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

China Primary Healthcare Foundation

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosed with prostate cancer and in need of ADT
Decision made to prescribe FIRMAGON® prior to enrollment
Willingness and ability to provide written informed consent
The participants are taking the marketed drug FIRMAGON®

Exclusion criteria

Not signed informed consent
Any participants who are unsuitable to participate in this study because of any other reasons will not be qualified to participate in this study.

Treatment and study plan

Degarelix Cohort

Other

Non-interventional

Other names: FIRMAGON®

Primary outcomes

Percentage of Participants With Any Adverse Events (AEs)

Time frame: From the signing of the informed consent up to the end-of-trial (12 months)

An AE was defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with treatment.
Percentage of Participants With Serious AEs

Time frame: From the signing of the informed consent up to the end-of-trial (12 months)

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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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 in Need of Androgen Deprivation Therapy

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Jan 6, 2022
Registry last updated: Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed