An open label, one-arm, multiple dose study in patients with prostate cancer to demonstrate efficacy of a one month goserelin 3.6 mg implant in a two months treatment (2 application periods) and PK/PD analysis of Zoladex® 3.6 mg implant in additional 12 patients.

Acino Supply AG0 个研究点目标入组 145 人开始时间: 2012年2月14日最近更新: 2015年8月4日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 145

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Male

入选标准

•1. Males between 18 and 89 years of age at the start and for the duration of the study
•2. Diagnosis of locally advanced, recurrent, or metastatic carcinoma of the prostate indicated for endocrine therapy
•3. Testosterone values of >1.5 ng/mL at Screening (Visit 1).
•4. Life expectancy of at least 6 months
•5. Written informed consent
•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 36
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 109

排除标准

•1. Hypersensitivity to Zoladex or to other gonadotropin releasing hormone (GnRH) analogs
•2. Previous androgen deprivation therapy, treatment with GnRH analogs, treatment with antiandrogens or androgen, receptor blockers is not allowed within 3 months before baseline, except treatment with non-steroidal antiandrogens as described in the protocol.
•3. Concomitant treatment with any GnRH analogs. Patients who previously underwent an intermittent treatment scheme may be included if no more than 2 treatment cycles were received. A treatment cycle is defined as the continuous and repeated administration of a GnRH analog (according to the prescribing information) until a discontinuation of treatment based on the patient's physical and / or disease status as
•judged by the investigator. The re-initiation of a subsequent GnRH analog administration (based on medical judgement) after the treatment discontinuation is defined as the start of a new treatment cycle.
•4. Considered for curative therapy i.e. radical prostatectomy or radiotherapy within 2 months from inclusion
•5. Cancer diagnosis within the last 5 years except prostate cancer, low grade bladder cancer, and surgically removed basocellular or squamous cell carcinoma of the skin
•6.Uncontrolled cardiac disease, including myocardial infarction within 12 months before screening, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of =3, unstable angina, abnormal blood pressure, severe cardiac arrhythmias, electrolyte abnormalities, congenital long QT syndrome, or cerebrovascular disease including stroke within 3 years of screening.
•7.History of abnormal blood pressure, unless adequately controlled with conventional treatment. Normal blood pressure is defined as BP <=140/90 mm Hg and >=90/60 mm Hg for those below 80 years of age, or <=150/90 mm Hg and >=90/60 mm Hg for those above 80 years of age. NOTE: In case patients present with abnormal BP readings at Visit 1 then they may get treated for hypertension by a doctor, and return for the Visit 2 assessments. If their BP values are found acceptable at Visit 2, they can still be included in the study.
•8.Concomitant medication of class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medications as well as bupropion, moxifloxacin, and SSRIs.
•9.Uncontrolled diabetes mellitus, or HbA1c>9%, at the time of screening or diabetic complications (retinopathy, neuropathy, nephropathy, PAD) within the past year.
•10.Medical history or concurrent condition of psychiatric disorders, such as psychotic disorders and depression.
•11.Medical history of seizures, convulsions, epilepsy, central nervous system anomalies, tumors, or anticonvulsive treatment.
•12.Medical history or current condition osteoporosis.
•13.Condition of ureteric obstruction or spinal cord compression.
•14.Previous orchiectomy, adrenalectomy, or hypophysectomy
•15. Medical history of any clinically significant neurological, gastrointestinal, renal, hepatic, respiratory, endocrine, hematological, dermatological or infectious disorder or other condition including alcohol or drug abuse, which may interfere with study participation or which may affect the conclusion of the study as judged by the investigator (using the ECOG [Eastern Cooperative Oncology Group] performance scale; patients who have an ECOG performance status of =3 will be excluded).
•16. Mental incapacity or language barriers p

研究者

发起方

Acino Supply AG

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