Patients who have advanced carcinoma of the prostate suitable for hormonal manipulation MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Novosis Leuprorelin 3.57 Implant
Pharmaceutical Form: Implant
INN or Proposed INN: Leuprorelin
CAS Number: 53714-56-0
Concentration unit: mg milligram(s)
Concentration type: equal
Trade
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 Enantone® 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 Simultaneous or less than 30 days earlier participation in another clinical trial Known allergy against one of the ingredients in the test and reference preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the AUC of the testosterone levels on Days 28, 35, 42, 49, and 56. The non-inferiority limit is stipulated as 80 % of the AUC of the reference product. If the two-sided 95 % confidence interval of the treatment effect lies completely above the non-inferiority margin, non-inferiority will be concluded;Main Objective: The aim of the study is to demonstrate that the Novosis Leuprorelin 3.57 mg implant is non-inferior to the reference product Enantone® Monats-Depot. Enantone® Monats-Depot has been chosen as the reference product as this is the originator product.;Secondary Objective: Percentage of patients who have reached castration level of testosterone (2 nmol/l) at the end of the study (Day 56). The plasma levels of leuprorelin and LH/FSH (Days 0, 7, 14, 21, 28, 35, 42, 49, 56) Number of non-responders The results of the clinical examination of the prostate Description of Adverse Events/Serious Adverse Events Assessment of tolerability | — |
Countries
Germany
Outcome results
None listed