Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05181800
Other study ID # 000351
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Active, not recruiting NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A