Department of Radiation Oncology, Tata Memorial Centre, Mumbai, India
Department of Radiation Oncology, Tata Medical Centre, Kolkata, India.
BMJ Open. 2020 Feb 28;10(2):e034623. doi: 10.1136/bmjopen-2019-034623.
There has been an interest in studying the efficacy of extreme hypofractionation in low and intermediate risk prostate cancer utilising the low alpha/beta ratio of prostate. Its role in high-risk and node-positive prostate cancer, however, is unknown. We hypothesise that a five-fraction schedule of extreme hypofractionation will be non-inferior to a moderately hypofractionated regimen over 5 weeks in efficacy and will have acceptable toxicity and quality of life while reducing the cost implications during treatment.
This is an ongoing, non-inferiority, multicentre, randomised trial (NCT03561961) of two schedules for National Cancer Control Network high-risk and/or node-positive non-metastatic carcinoma of the prostate. The standard arm will be a schedule of 68 Gy/25# over 5 weeks while the test arm will be extremely hypofractionated radiotherapy with stereotactic body radiation therapy to 36.25 Gy/5# (7 to 10 days). The block randomisation will be stratified by nodal status (N0/N+), hormonal therapy (luteinizing hormone-releasing hormone therapy/orchiectomy) and centre. All patients will receive daily image-guided radiotherapy.The primary end point is 4-year biochemical failure free survival (BFFS). The power calculations assume 4-year BFFS of 80% in the moderate hypofractionation arm. With a 5% one-sided significance and 80% power, a total of 434 patients will be randomised to both arms equally (217 in each arm). The secondary end points include overall survival, prostate cancer specific survival, acute and late toxicities, quality of life and out-of-pocket expenditure.
The trial aims to establish a therapeutically efficacious and cost-efficient modality for high-risk and node-positive prostate cancer with an acceptable toxicity profile. Presently, this is the only trial evaluating and answering such a question in this cohort.
The trial has been approved by IEC-III of Tata Memorial Centre, Mumbai.
Registered with CTRI/2018/05/014054 (http://ctri.nic.in) on 24 May 2018.
人们一直对利用前列腺的低α/β比值研究低危和中危前列腺癌的极端超分割放疗的疗效感兴趣。然而，其在高危和淋巴结阳性前列腺癌中的作用尚不清楚。我们假设五剂量的极端超分割方案在疗效上不亚于 5 周的中度超分割方案，同时具有可接受的毒性和生活质量，并且在治疗期间降低成本。
这是一项正在进行的、非劣效性、多中心、随机试验（NCT03561961），研究了两种方案用于国家癌症控制网络高危和/或淋巴结阳性非转移性前列腺癌。标准组将接受 68Gy/25#，共 5 周；而实验组将接受立体定向体部放射治疗 36.25Gy/5#（7-10 天）的极端超分割放疗。分组随机化将按淋巴结状态（N0/N+）、激素治疗（促黄体生成素释放激素治疗/睾丸切除术）和中心进行分层。所有患者都将接受每日图像引导放疗。主要终点是 4 年生化无复发生存率（BFFS）。计算功效假设中度超分割组的 4 年 BFFS 为 80%。单侧 5%显著水平和 80%功效，总共将有 434 名患者随机分为两组，每组各 217 名。次要终点包括总生存、前列腺癌特异性生存、急性和晚期毒性、生活质量和自付费用。
该试验旨在为高危和淋巴结阳性前列腺癌建立一种治疗有效且具有成本效益的方法，同时具有可接受的毒性特征。目前，这是唯一一项在该队列中评估和回答此类问题的试验。
该试验已获得孟买塔塔纪念中心 IEC-III 的批准。
于 2018 年 5 月 24 日在 CTRI（http://ctri.nic.in）注册，注册号为 CTRI/2018/05/014054。
