Dose Intensification With a Focal Boost to Dominant Intraprostatic Lesion Using Volumetric Modulated Arc Therapy /Image Guided Radiotherapy in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of Participants With Biochemical Failure at 5 Years
研究概览
简要总结
The aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
详细描述
The aim of this study was to determine the efficacy and safety of the implementation of a program of " image-guided focal Intensification dose to intraprostatic dominant lesion " in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy in the Department of Radiation Oncology of HUP (Hospital Universitario de La Princesa), within the established dose escalation protocol with intensity modulated image-guided radiotherapy (IMRT / IGRT).
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male > 18 years old with histologic diagnostic of prostate adenocarcinoma
- •Clinical stage cT2a-T3b N0-1 M0 (AJCC 7 th edition)
- •PSA (prostate-specific antigen) < 100 ng/ml
- •Gleason score 6-10
- •Life expectancy > 5 years
- •Patients who accept the radiotherapy treatment
- •Patients provided written informed consent before participating in the trial
排除标准
- •Transurethral resection of the prostate or prior prostate surgery
- •Previous pelvic radiotherapy
- •Urethral stenosis with or without prior dilations
- •Rectal diverticuli or rectal vascular malformations
- •Metastatic disease
- •Severe psychiatric or medical conditions that could hamper both treatment and follow-up
结局指标
主要结局
Number of Participants With Biochemical Failure at 5 Years
时间窗: 5 years
Biochemical failure determined according to the Phoenix definition (nadir PSA + 2 ng/ml)
Acute and Late Rectal and Urinary Complications
时间窗: 5 years
Acute and late rectal and urinary complications defined as the number of participants with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events CTCAE v4.0 and Radiation- Therapy Oncology Group/ European Organization for Research and Treatment of Cancer RTOG/EORTC scales (been 0: no toxicity and 4: most severe toxicity).
Local Control
时间窗: 6 and 9 months following radiotherapy
An image complete response was defined as disappearance of all morphological and functional lesions in mpMRI 6 to 9 months after radiotherapy.
次要结局
- Number of Participants Free of Biochemical Progression(5 years)
- Disease-free Survival (DFS)(5 years)
- Verification of Safety Margins(5 years)
- Quality of Life (QoL) Assessed by the Expanded Prostate Cancer Index Composite EPIC16 Scale 0-60 (Best to Worst). The Total Score of the Scale is the Summatory of the Domain's Score(5 years)