Male patients with carcinoma of the prostate aged 18 years and more and suitable for hormonal manipulation MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Novosis Leuprorelin
Pharmaceutical Form: Implant
INN or Proposed INN: leuprorelin
CAS Number: 74381-53-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
Novosis AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Males aged 18 years or older • Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising PSA after having undergone surgery or radiotherapy with curative intention • Life expectancy of at least six months • The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form • The patient is able to understand and follow instructions and is able to participate in the study for the entire period • Patients must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures. 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: • Hypersensitivity to Trenantone® or to other GnRH analogues • Treatment with a drug modifying testosterone level or function is prohibited. To these belong e.g. flutamide, spironolactone, domperidone, cimetidine, amitriptyline, methyldopa, minoxidil, and finasteride • Treatment and/or pretreatment with other GnRH analogues • Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion • Cancer disease within the last 10 years except prostate cancer, and surgically removed basocellular or squamous cell carcinoma of the skin • Patients with clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or any infectious disorder 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 • Mental incapacity or language barriers precluding adequate understanding or co-operation • Patients who have received an investigational drug within the last 12 weeks preceding Visit 1 • Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the new Novosis Leuprorelin 10.72 mg implant is therapeutically non inferior to the reference product Trenantone® Primary variable: Area under the curve (AUC) of the testosterone levels on Days 28, 42, 56, 70, 84;Secondary Objective: - Testosterone levels on days 0, 14, 28, 42, 56, 70, 84 - percentage of patients who have reached castration level of testosterone (2 nmol/l)at the end of the study (Day 84) - the plasma levels of leuprorelin and LH/FSH (Days 0, 14, 28, 42, 56, 70, 84), - number of non-responders, ;Primary end point(s): Primary variable: Area under the curve (AUC) of the testosterone levels on Days 28, 42, 56, 70, 84 | — |
Countries
Hungary
Outcome results
None listed