Effect of Statins on a Prognostic Plasma Lipid Signature in Metastatic Castration-Resistant Prostate Cancer

Chris O'Brien Lifehouse0 个研究点目标入组 60 人开始时间: 2017年7月5日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•1. Males with castration-resistant metastatic prostate cancer (as per PCWG3) AND commencing docetaxel, cabazitaxel, abiraterone or enzalutamide for disease progression
•2. Age 18 yrs or over
•3. WHO ECOG performance status 0-2
•4. Histological confirmation of prostate cancer
•5. Adequate hepatic function with serum total bilirubin < 1.5 x upper limit of normal range and ALT and AST < 2.5x upper limit of normal range (or < 5.0 times ULN with documented liver metastases), serum albumin > 25 g/L, and ALP < 5x upper limit of normal range
•6. Adequate renal function (with calculated creatinine clearance >50 ml/min based on the Cockcroft-Gault method, 24 hour urine or GFR scan) and serum creatinine < 1.5 x upper limit of normal range;
•7. Willing and able to comply with all study requirements, including treatment and biospecimen collection
•8. Signed written informed consent

•1. Patients already receiving a lipid lowering agent(s), or have received one in the last 4 weeks
•2. Known hypersensitivity to statins or its excipients
•3. Prior myopathy with a lipid lowering agent
•4. Active hepatic disease, including chronic active hepatitis B or hepatitis C. Testing for these is not mandatory unless clinically indicated.
•5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

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