Prostate cancer MedDRA version: 7.0 Level: pr t Classification code 10060862
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Each patient must meet the following inclusion criteria before entry into the study: 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 whom 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 >1.5 ng/mL. 5. Has an ECOG (Eastern Cooperative Oncology Group) score of = 2. 6. Has a screening PSA value of =2 ng/mL. 7. Has a life expectancy of at least 12 months. 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: Any patient meeting one or more of the following exclusion criteria may not be entered into the study: 1. Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including LHRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens). However, patients having undergone prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months. This treatment should have been terminated at least 6 months prior to Screening Visit. 2. Is currently treated with an 5-a-reductase inhibitor. 3. Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy. 4. Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema. 5. Has hypersensitivity towards any component of the investigational products (see protocol section 6.2 Investigational Medicinal Products). 6. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms). 7. A history of additional risk factors for Torsade de Pointes ventricular arrhythmias (e.g., heart failure, hypokalemia, family history of Long QT Syndrome). 8. The use of concomitant medications that prolong the QT/QTc interval. 9. Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin. 10. Has a known or suspect hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment). 11. Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range as measured by the laboratory at the Screening Visit and confirmed with a second measurement within 21 days. 12. Has other clinically significant laboratory abnormalities which in the judgment of the investigator would interfere with the patient’s participation in this study or evaluation of study results. 13. Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator. 14. Has a mental incapacity or language barriers precluding adequate understanding or co operation. 15. 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. 16. Has previously participated in any degarelix study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: •To demonstrate non-inferiority with respect to the proportion of patients achieving and maintaining testosterone suppression to castrate levels using a degarelix dosing regimen compared to LUPRON DEPOT® during 12 months treatment ;Secondary Objective: Secondary Objectives: •To compare serum levels of testosterone and PSA using a degarelix dosing regimen versus LUPRON DEPOT® during the first 28 days of treatment. •To compare the safety and tolerability using a degarelix dosing regimen versus LUPRON DEPOT®. •To compare testosterone, LH, FSH, and PSA response using a degarelix dosing regimen versus LUPRON DEPOT® during the entire treatment period. •To compare Patient Reported Outcomes (Quality of Life and hot flash/flushes) using a degarelix dosing regimen versus LUPRON DEPOT® during treatment. •To evaluate the pharmacokinetics using a degarelix dosing regimen.;Primary end point(s): Primary efficacy criteria: • Proportion of patients with testosterone levels = 0.5 ng/mL from Day 28 through Day 364. | — |
Countries
Czech Republic, Germany, Hungary, Spain, United Kingdom
Outcome results
None listed