Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy
研究概览
简要总结
This is an investigator-initiated phase II single arm trial, combining neoadjuvant apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate resistant prostate cancer in phase II studies and are now in phase III trials combined with radiation in organ confined disease.
The primary study objectives include assessment of (i) oncological efficacy as determined by tumour downstaging and achievement of nadir PSA The secondary study objectives include(i) determination of adverse effects related to apalutamide and surgical complication rates (ii) human prostate tissue effect of apalutamide
The study will recruit thirty eligible participants who will receive 12 weeks of oral apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The total trial duration is 26 weeks.
详细描述
This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases.
Safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histologically diagnosed primary adenocarcinoma of the prostate gland
- •non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
- •no known hypersensitivity to the study drug
- •able to swallow study drug as whole tablets
排除标准
- •presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
- •individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
- •patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
- •renal impairment with serum creatinine more than twice the upper limit of normal
- •Other prior malignancy less than or equal to 5 years prior to recruitment
- •ECOG performance status 2 or poorer
研究组 & 干预措施
Neoadjuvant apalutamide
Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection
干预措施: Apalutamide (Drug)
结局指标
主要结局
Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy
时间窗: 24 weeks
This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy
Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy
时间窗: 24 weeks
Patients who attain serum PSA levels below 0.03microg/L
次要结局
- Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide(12 weeks)
- The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy(24 weeks)