Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ferring Pharmaceuticals
With
Ferring Pharmaceuticals Korea, Ltd.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Has given written informed consent before any trial-related activity is performed.
Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages) (except for neoadjuvant hormonal therapy/ includes patients with rising PSA after prostatectomy or radiotherapy)
Is a male patient aged 18 years or older
Has a screening serum testosterone level \>1.5 ng/mL
Has an ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
Has a screening PSA value of ≥2 ng/mL
Has a life expectancy of at least 12 months
You may not be if
Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
Is currently treated with a 5-α-reductase inhibitor
Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
Has hypersensitivity towards any component of the investigational medicinal product
A marked baseline prolongation of QT/QTcF interval
A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
Has a known or suspect hepatic, symptomatic biliary disease
Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
Has other clinically significant laboratory abnormalities
Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
Has a mental incapacity or language barriers precluding adequate understanding or co- operation
Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
Has previously participated in any degarelix trial
Clareo Health | Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer
