An open label, multiple dose, Phase III clinical study in patients with prostate cancer to investigate the clinical efficacy of AMW goserelin 3.6 mg implant in its application system

AMW GmbH0 个研究点开始时间: 2015年9月15日最近更新: 2017年2月6日

适应症

试验速览

暂无简介。

•Males aged 18 years or older
•Histologically confirmed diagnosis of carcinoma of the prostate suitable for hormonal manipulation including patients with rising prostate-specific antigen (PSA) after having undergone surgery or radiotherapy with curative intention
•Normal testosterone value (> 10.4 nmol/l or > 3 ng/ml) at screening, according to immunoassay
•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 study period
•Patient has given his 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 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•Hypersensitivity to Zoladex (registered trademark) or to other GnRH analogues
•Treatment with GnRH analogues, completed less than 6 months prior to the baseline visit
•Patients considered being candidates for curative therapy i.e. radical prostatectomy or radiotherapy within 6 months from inclusion
•Cancer disease within the last 5 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
•Previous participation in this study
•Simultaneous or less than 12 weeks earlier participation in another clinical trial
•Known allergy against one of the ingredients in the test preparation

发起方