EnzAdapt: Feasibility, acceptability and safety of adaptive dosing of enzalutamide in men with metastatic castrate-resistant prostate cancer

Calvary Mater Newcastle0 个研究点目标入组 15 人开始时间: 2019年4月11日最近更新: 2020年9月21日

适应症

试验速览

暂无简介。

•Participants are eligible to be included in the study only if all of the following criteria apply:
•·Histologically or biochemically confirmed adenocarcinoma of the prostate
•·Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy (i.e., surgical or medical castration with testosterone at screening <0.5 ng/L)
•oPatients who have not had a bilateral orchiectomy, must have a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
•·Metastatic castration resistant prostate cancer (CRPC)
•·Prior treatment with taxane chemotherapy, (e.g. docetaxel and/or cabazitaxel) or predicted to be intolerant and not eligible for future chemotherapy
•·Controlled symptoms (opioids for cancer related pain stable for > 4 weeks, no need for urgent radiotherapy for symptomatic lesions)
•·Metastatic disease defined as at least 1 documented metastatic lesion on either a whole body bone scan or a CT scan of the chest, abdomen and pelvis.
•·Participant has chosen to take enzalutamide as standard of care treatment for CRPC

•·Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
•·Known or suspected brain metastasis or active leptomeningeal disease;
•·Any other therapies for CRPC (excluding denosumab) to be discontinued 3 weeks prior to study.
•·Prior treatments with CYP17 or androgen receptor inhibitors (abiraterone or enzalutamide prior to this course). Prior treatment with docetaxel or cabazitaxel is allowed.
•·Documented liver metastases

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