Open-labelled single-arm phase II clinical trial of triplet therapy (ADT + DAR + biweekly DTX) for high-risk metastatic castration-sensitive prostate cancer (Open-labelled single-arm phase II clinical trial of triplet therapy (ADT + DAR + biweekly DTX) for high-risk metastatic castration-sensitive prostate cancer)

未提供0 个研究点目标入组 30 人开始时间: 2025年1月8日最近更新: 2025年1月10日

试验速览

暂无简介。

•Metastatic castration-sensitive prostate cancer
•Histologically adenocarcinoma
•Age greater than or equal to 20 years
•Performance Status (ECOG) 0-2
•Meet the following high-risk criteria
•Gleason pattern 5 is present.
•BSI* 1.5 and above *BSI: bone scan index
•LDH 300 IU/L and above
•Meet at least two out of the following three criteria.
•(6) The patient's free and voluntary written consent has been obtained after sufficient informed consent for participation in the clinical research.

•Patients already receiving any treatment for mCSPC (with the exception of ADT or CAB in the 3 months prior to the start of this study)
•Patients who have participated in other clinical studies (clinical trials) within 3 months prior to the start of study drug administration
•Patients with known hypersensitivity to ADT, DAR or DTX
•Patients with severe myelosuppression
•Patients with concomitant infections or suspected infections
•Patients with severe (Child-Pugh Classification C) hepatic dysfunction
•Patients with end-stage renal failure on dialysis or with an eGFR of less than 15 mL/min/1.73 m
•Patients who are judged to be unsuitable as research subjects by the principal investigator or a sub-investigator.

PSA response rate

未报告次要终点

发起方

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