TaxAdapt: Feasibility, acceptability and safety of adaptive dosing of docetaxel 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: 2021年6月11日最近更新: 2021年6月21日

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) (NB Patients 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)
•· 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

•· Prior treatment with taxane chemotherapy, (e.g. docetaxel and/or cabazitaxel)
•· 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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