Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Acute gastrointestinal and genitourinary toxicity
研究概览
简要总结
The AFFIRM trial tests the safety and clinical feasibility of MR-guided hypofractionated focal boost radiotherapy for patients with locally advanced prostate cancer. External beam radiotherapy combined with androgen deprivation therapy is considered as the treatment of choice for patients with locally advanced non-metastatic prostate cancer with seminal vesicle invasion.The long-term results of the multicentre phase III study (FLAME trial) showed that addition of an isotoxic focal boost to the intraprostatic lesion improves biochemical disease free survival in intermediate to high-risk patients without impacting toxicity and quality of life.
This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 years or older with histologically proven prostate carcinoma
- •Imaging stage T3b (as defined on mpMRI) N0M0
- •Intraprostatic lesion visible on MRI
- •Capable of giving informed consent
排除标准
- •History of radiotherapy to the pelvis or transurethral resection of the prostate (TURP)
- •Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
- •Absence of pre-treatment PSMA PET CT
- •WHO performance score > 2
- •International Prostate Symptom Score ≥ 15
- •PSA > 30
- •Prostate volume >100c
结局指标
主要结局
Acute gastrointestinal and genitourinary toxicity
时间窗: 90 days after start of treatment
Acute gastrointestinal (GI) and genitourinary (GU) Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Acute toxicity is defined as toxicity occurring within 90 days after the first radiation treatment (e.g. 60 days after completion of the radiation treatment).
次要结局
- Quality of life(from baseline up to 5 years after completion of treatment)
- Late GI and GU toxicity (CTCAE v5.0)(from 90 days after start of treatment up to 5 years)
- Prostate cancer specific survival(up to 5 years after completion of treatment)
- Biochemical disease free survival(up to 5 years after completion of treatment)
- Distant metastasis free survival(up to 5 years after completion of treatment)
- Overall survival(up to 5 years after completion of treatment)