To assess the efficacy of low dose Abiraterone (250 mg (1 tablet) once daily taken along with food) in comparison to the standard dose Abiraterone (1000 mg (4 tablets) taken in fasting state) in patients with Metastatic Castrate Resistant Prostate Cancer.

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

暂无简介。

•1.Histologically or cytologically confirmed prostate cancer with progressive disease defined as either: Radiographic progression, PSA Progression OR Evidence of castration resistance defined as disease progression despite a testosterone level Ã¢â?°Â¤ 50 ng/dL (or surgical castration)
•2.Denosumab or zoledronic acid are allowed
•3.ECOG 0,1,2
•4.Patients must have normal hepatic function as defined below- a)Total bilirubin < 1.5 x the upper limit of normal b)AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

•a)Inability to swallow capsules or gastrointestinal malabsorption
•b)Patients who have taken abiraterone in the hormone sensitive prostate cancer (HSPC) setting
•c)History of other malignancies with exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or curatively treated solid and hematological tumors with no evidence of disease for Ã¢â?°Â¥ 3 years from enrollment
•d)Serum K+ less than 3.5 mmol/L
•e)Uncontrolled intercurrent infection or other uncontrolled medical illness
•f)Active psychiatric illness which would limit compliance
•g)New York Heart Association (NYHA) class II, III or IV heart failure
•a.NYHA Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
•b.NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20Ã¢â?¬â?100 m). Comfortable only at rest.
•c.NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
•h)Concurrent therapy with strong inhibitors or inducers of CYP3A4 Use of an investigational product within the prior 30 days

发起方