Pilot study to evaluate the prognostic and metabolic effects of metformin during treatment of metastatic prostate cancer with androgen deprivation therapy

Queensland University of Technology0 个研究点目标入组 80 人开始时间: 2014年10月2日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Age above 18 years
•2.Competent to understand information and provide written informed consent
•3.Metastatic prostate adenocarcinoma defined by radiological diagnosis (TNM staging), PSA greater or than equal to 20 in the presence of tissue diagnosis or abnormal prostate examination, PSA recurrence post surgery or radiotherapy
•4.No prior chemotherapy for prostate cancer
•5.Not on insulin control medications [Insulin, oral hypoglycaemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose]
•6.Adequate renal function (Creatinine equal to 177mmol/L, GFR greater than 30 mls/min)
•7.Adequate hepatic function (Bilirubin must be equal to 1.5 x upper limit of normal range, ALT and ALP must be equal to 2.5 x upper limit of normal)
•8.Life expectancy greater than 6 months

•1.Known brain metastasis
•2.Malignant disease other than prostate cancer at the time of enrolment, apart from completely treated non-melanomatous skin malignancy
•3.Prior chemotherapy for prostate cancer
•4.Prior primary radiotherapy within 6 weeks
•5.Previously treated with ketoconazole for greater than 7 days
•6.Prior systemic treatment with an azole drug within 4 weeks
•7.Prior antiandrogen treatment within 6 weeks
•8.History of lactic acidosis
•9.History of pituitary or adrenal dysfunction
•10.Cardiac (heart failure NYHA class II or greater, acute myocardial infarct, unstable angina, arterial-thromboembolic event within past 6 months) or respiratory insufficiency (active pulmonary embolism, severe chronic obstructive pulmondary disease), severe liver failure (cirrhosis with a Child-Pugh level of B or greater), severe infection that is likely to increase the risk of lactic acidosis
•11.Medical or psychiatric conditions that compromise the patient's ability to give informed consent
•12.History of pituitary or adrenal dysfunction
•13.Participants will be discharged from the study if unable to tolerate metformin due to adverse reactions or develop medical conditions such as renal failure or diabetes requiring additional agents other than metformin

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