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 人开始时间: 2018年1月22日最近更新: 2020年2月1日

试验速览

暂无简介。

•-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.
•-Low of intermediate risk according to NICE classification
•-MRI score of = 3 using PIRAD version 2 reporting criteria
•- Adequate haematological, renal and liver organ function (measured within 14 days prior to planned first trial drug administration)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•-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.
•- Patient unsuitable to participate as unlikely to comply with trial procedures, as judged by the investigator
•- Patient with previous non-related malignancy that have undergone treatment with curative intent or who are ongoing treatment
•- Participation in any other clinical trials involving an IMP or interventional delivery

发起方

Cambridge University Hospitals NHS Foundation Trust & The University of Cambridge