prostate cancer MedDRA version: 12.0 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Acino Goserelin 10.8 mg Implant
Product Code: 30060
Pharmaceutical Form: Implant
INN or Proposed INN: goserelin
CAS Number: 65807-02-5
Current Sponsor code: 30060
Concentration unit: mg
Sponsors
Acino Supply 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 Normal testosterone values (> 3ng/mL) at screening and baseline visit 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 Zoladex? or to other GnRH analogues 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 preparation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the new ACINO Goserelin 10.8 mg Implant leads to a consistent and clinically meaningful suppression of testosterone levels below castrate level (0.5 ng/mL) that can be maintained for the rest of the active treatment phase once it has been achieved. Primary variable: Testosterone levels on Days 28, 42, 56, 70, 84, 88, 98, 112, 126, 140, 154 and 168;Secondary Objective: Efficacy Area-under-the-curve (AUC) of the testosterone levels on Days 28, 42, 56, 70, 84, 88, 98, 112, 126, 140, 154 and 168 percentage of patients who have reached castration level of testosterone (0.5 ng/mL) at the end of the study (Day 84), the plasma levels of goserelin and LH/FSH (Days 0, 14, 28, 42, 56, 70, 84, 88, 98, 112, 126, 140, 154 and 168), number of non-responders, the results of the clinical examination of the prostate Safety Description of Adverse Events/Serious Adverse Events Assessment of tolerability ECG at the days of implantation, prior to implantation and at study end Safety laboratory at the days of implantation, prior to implantation and at study end. ;Primary end point(s): none | — |
Countries
Germany
Outcome results
None listed