CyberKnife Ultra-hypofractionated SBRT for Localized PROStatE cancEr With Dose-escalation to the Dominant Intraprostatic Lesion: is the Juice Worth the Squeeze? The PRO-SPEED Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of patient-reported toxicity
研究概览
简要总结
This is a prospective observational study. The study will proceed with the enrollment of 60 patients in 2 years. he aim of the present study is to evaluate effectiveness of ultra-hypofractionated (UH) CyberKnife Stereotactic Body Radiation Therapy treatment on the whole prostate gland plus Simultaneous integrated boost (SIB) to the dominant intraprostatic lesions (DIL(s) in intermediate-unfavourable to high-risk Prostate Cancer (PCa) patients.
详细描述
The patient to be enrolled in the prospective observational phase will be screened at first visit; prescription of Prostate Specific Antigen (PSA) and testosterone analysis, uroflowmetry and multiparametric Magnetic Resonance Imaging (mpMRI) are mandatory if not already done.
Additional staging imaging (computed tomography (CT) and/or bone scan) will be required according to National Comprehensive Cancer Network (NCCN) category risk group.
Subsequently, for the eligible patient, the enrollment phase involves eco-guided transrectal insertion of 3-4 gold fiducials in the prostate gland.
CT with full bladder and empty rectum will be done after 7-10 days from fiducials insertion; CyberKnife-Stereotactic Body Radiation Therapy (SBRT) treatment will start after 5-7 days from the simulation CT. A total of 36.25 Gy to the prostate gland will be executed in 5 alternate days. For each treatment delivery, the patient is required to be prepared in roughly the same bladder and rectum filling condition of the simulation day. Finally, in the last treatment day QoL and both clinician- and patient-reported genitourinary (GU) and gastrointestinal (GI) acute toxicity assessment is required.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 80 years
- •Histologically confirmed adenocarcinoma of the prostate
- •Low, Intermediate and high-risk category according to NCCN version 02.2021
- •Clinically node negative and no distant metastasis
- •Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- •Good urinary flow (peak flow >10 mL/s) or IPSS < 15
- •Prostate volume < 100 cc
- •Available mpMRI of the prostate
- •Less than 3 DILs at mpMRI (if >2 DILs, only DILs with higher Prostate Imaging - Reporting and Data System (PIRADS) will be included and only PI-RADS >2)
- •Written informed consent for treatment and research purpose
排除标准
- •platelets count < 75000
- •urethral stricture
- •Previous pelvic RT
- •Concomitant inflammatory bowel disease or other serious systemic comorbidities
- •Previous prostatectomy
- •Presence of hip prosthesis
结局指标
主要结局
Evaluation of patient-reported toxicity
时间窗: 24 months
Evaluation of patient-reported toxicity using International Prostatic Symptoms Score IPSS
Number of Participants with Acute GU and GI toxicities (RTOG)
时间窗: 3 months
Evaluation of acute genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
Evaluation of patient-reported quality of life
时间窗: 24 months
Evaluation of patient-reported toxicity using International Index of Erectile Function Questionnaire
Number of Participants with Late GU and GI toxicities (RTOG)
时间窗: 24 months
Evaluation of late genitourinary and gastrointestinal toxicity using Radiation Toxicity Grading (RTOG) distinguishing between lower toxicities (G1 and G2) and worse toxicities (G3 and G4)
次要结局
未报告次要终点