FIRMAGON® Intensive Drug Monitoring

Ferring

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Degarelix Cohort

Study type: Observational

Funder types: Industry

Identifiers

NCT05181800

000351

Details and patient eligibility

About

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.

Enrollment: 1,454 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,454 participants in 1 patient group

FIRMAGON® Cohort

Treatment:

Other: Degarelix Cohort