prostate cancer suitable for hormonal manipulation
Conditions
Interventions
Trade Name: Zoladex
Product Name: Zoladex
Pharmaceutical Form: Implant
INN or Proposed INN: goserelin acetate
CAS Number: 65807-02-5
Concentration unit: mg milligram(s)
Product Name: Novosis Gosereli
Sponsors
NOVOSIS AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males aged 18 years or older Confirmed new diagnosis of advanced carcinoma of the prostate suitable for hormonal manipulation 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? 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 Zoladex® or to other GnRH analogues Treatment with a drug modifying testosterone level or function is prohibited. 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 |
|---|---|
| Main Objective: To demonstrate that the new Novosis Goserelin 10.8 mg implant is therapeutically equivalent to the Zoladexâ 10.8 mg (ASTRA-ZENECA) and to the Novosis Goserelin 3.6 mg implant applied every 28 days for 3 months (AUA of the testosterone levels on days 28, 42, 56, 70 and 84.;Primary end point(s): ;Secondary Objective: Efficacy: Testosterone levels on Days 28, 42, 56, 70, 84 Percentage of patients who have reached castration level of testosterone (2 nmol/l) at the study end (Day 84). Plasma levels of goserelin (days 0, 28, 56, 84). The results of the clinical examination of the prostate including PSA. Safety: Description of AEs/SAEs Assessment of tolerability ECG at day 0 and at study end Vital signs at all visits Safety labs prior to implantations and at study end | — |
Countries
Hungary
Outcome results
None listed