Targeted drug intervention to inhibit cancer progression in men on active surveillance for prostate cancer. Therapeutics in Active Prostate cancer Surveillance (TAPS01) - TAPS01

Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge0 个研究点目标入组 10 人2018年1月22日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge
入组人数: 10
状态: 进行中（未招募）
最后更新: 6年前

暂无简介。

注册库

who.int

开始日期

2018年1月22日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

发起方

Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge

•\-Given Informed Consent (IC) to participate
•\-Age 18 or over
•\-ECOG status 0\-2
•\-Diagnosed with prostate cancer
•\-Patient selection of active surveillance as a management option
•\-mpMRI detectable lesion
•\-Prostate cancer on biopsy from a mpMRI defined lesion
•\-Willing to use two high effective forms of contraception throughout their participation in the trial and for three months after their last dose
•\-Normal full blood count and normal renal and liver function tests
•\-At least 6 months since initiation of active surveillance and/or last rebiopsy date.

•\-Contraindication to apalutamide or its excipients
•\-Concurrent medication that can lower seizure threshold
•\- Clinically significant change in tumour volume as assessed by mpMRI at the baseline in comparison with the previous standard of care mpMRI prior to enrolment into the trial
•\-Prior localised or systemic therapy for prostate cancer
•\-Prior use of androgen deprivation therapy or androgen receptor targeting agents
•\-Prior systemic therapy for prostate cancer
•\-Patient unable to have prostate 3T mpMRI scan
•\-Presence of any pelvic or hip metalwork
•\- Conditions resulting in the inability to swallow or absorb the trial drug or contrast agents
•\- Poor medical risk due to uncontrolled medical disorder, non\-malignant systemic disease or active, uncontrolled infection, or as judged by the investigator.