Patients with prostate cancer requiring androgen ablation therapy MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Has given written informed consent before any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient. 2.Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), in which androgen ablation treatment, except for neoadjuvant hormonal therapy, is indicated. This includes patients with rising PSA after having undergone prostatectomy or radiotherapy with curative intention. 3.Is a male patient aged 18 years or older. 4.Has a screening serum testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL. 5.Has an ECOG (Eastern Co-operative Oncology Group) score of ?2 (see Appendix 7). 6.Has a screening PSA value of ?2 ng/mL. 7.Has a life expectancy of at least one year. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has had previously or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens). However, for patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to Screening Visit. 2.Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy. 3.Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema. 4.Has hypersensitivity towards any component of the investigational medicinal product (see section 6.2). 5.Has a marked baseline prolongation of QT/QTc interval. 6.Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome). 7.Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. 8.Has a known or suspected clinically significant liver and/or biliary disease. 9.Has any clinically significant laboratory abnormalities which in the judgment of the investigator would affect the patient’s health or the outcome of the study. 10.Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse, which may affect the patient’s health or the outcome of the study as judged by the investigator. 11.Has a mental incapacity or language barriers precluding adequate understanding or co-operation. 12.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 study. 13.Has previously participated in any degarelix study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the degarelix dosing regimen that most effectively achieves and maintains testosterone suppression at castrate levels during one year of treatment.;Secondary Objective: To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. To evaluate degarelix pharmacokinetics. To compare safety and tolerability profiles of different three-month dosing regimens. ;Primary end point(s): Probability of testosterone at castration level (=0.5 ng/mL) from Day 28 through Day 364 | — |
Countries
Czech Republic, Hungary
Outcome results
None listed