Phase II Randomized Control Trial Comparing Radical Hypofractionated Radiotherapy to Prostate Only VS Prostate And Pelvic Lymph Nodes in Intermediate And High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
This phase II randomized controlled study aims to compare the treatment results of intermediate and high risk prostate cancer patients treated with hormonal therapy and radical radiotherapy with or without pelvic lymph nodes in NCI- Cairo University.
详细描述
Study Design :
Phase II prospective randomized trial with 2 arms • Prostate Only (Arm A)
Hypofractionated Intensity modulated radiotherapy (IMRT) to the prostate only to dose of 60Gy/20fractions (3 Gy per fraction)
• Prostate & Pelvic Lymph Nodes (Arm B)
Hypofractionated Intensity modulated radiotherapy (IMRT) with elective pelvic nodes irradiation up to 44Gy/20 fractions (2.2 Gy per fraction) with a Simultaneous Integrated Boost (SIB) to the prostate to dose of 60Gy/20fractions (3 Gy per fraction)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically-proven prostatic adenocarcinoma.
- •Risk stratification from intermediate to very high risk will be included according to NCCN guide lines September 5, 2019 version 4.2019:
- •Intermediate risk: T2b or T2c and/or GS =7 and/or PSA >10-
- •Both the favorable intermediate (1 intermediate risk factor (IRF) and Grade Group 1 or 2 and <50% biopsy core positive) and unfavorable intermediate risk (2 or 3 IRFs and/or Grade Group 3 and/or ≥50% biopsy cores positive) will be included.
- •High risk: T3a or PSA >20 or Grade Group 4 or 5, not very high risk.
- •Very high risk: T3b-4, primary gleason pattern 5 OR >4 cores with grade group 4 or 5
- •N stage: N0
- •M Stage: M0
- •Performance Status: PS 0-2
排除标准
- •Low risk prostate cancer
- •Histologies other than adenocarcinoma
- •Patients with significant comorbidities might affect treatment completion and follow up
- •Previously received pelvic radiotherapy
- •Patients with metastatic disease
- •Poor performance status (PS ≥ 3)
结局指标
主要结局
Acute toxicity
时间窗: 90 days post the end of radiation therapy
Compare Acute toxicity between the 2 arms using Radiation Therapy Oncology Group (RTOG) acute morbidity scoring criteria.
Local Control
时间窗: 1 year
Compare Local control (LC) with minimum follow up of 1 year in both groups
次要结局
- Biochemical free survivals (BFS)(1 year)
- Late toxicity(1 year)
- Overall survival (OS)(1 year)
研究者
Ahmed Abdelhamid
Assistant Lecturer Of Radiation Oncology - National Cancer Institute
Cairo University