Role of Abiraterone plus Prednisolone with Androgen Deprivation Therapy (ADT) versus ADT alone in Hormone Sensitive Metastatic Carcinoma Prostate in Indian men;A RCT.

AIIMS Bhubaneswar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Men aged 18 years and older with newly diagnosed and histologically or cytologically confirmed adeno- carcinoma of the prostate without neuroendocrine differentiation or small cell histology, with distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI as per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria, and with Eastern Cooperative Oncology Group (ECOG) performance status score of 0â??2 were included. Additionally, patients were required to have at least two of three high-risk prognostic factors (Gleason score >=8, three or more lesions on bone scan, and measurable visceral metastases, excluding lymph node metastasis). Patients were also required to have adequate haematological, hepatic, and renal function .
•2.Written informed consent.

•1.Patients with small-cell carcinoma of the prostate, brain metastasis, uncontrolled hypertension, or with clinically significant cardiac, adrenal, or liver disease, or malignancy other than prostate or non-melanoma skin cancer within the previous 5 years were excluded.
•2. Patients who had received previous chemo- therapy, radiotherapy, or surgery for metastatic prostate were excluded.

发起方