Fractionated Stereotactic Ablative Body Radiotherapy (SBRT) With FOcal Dose Escalation on Dominant Lesion in Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Local control
研究概览
简要总结
Stereotactic ablative Body Radiotherapy (SBRT) is an advanced radiation technique that allows for precise delivery of higher radiation doses in fewer treatment sessions, resulting in a shorter overall treatment duration. The available clinical evidence suggests that SBRT is highly effective in controlling localized prostate cancer (PCa) with acceptable side effects.
On the other side, dose escalation is a commonly employed strategy in radiotherapy for prostate cancer. Recent studies have confirmed a dose-response relationship, demonstrating improved biochemical control with focal dose escalation to the identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) of the prostate.
The hypothesis of this study is that the combination prostate SBRT with focal dose intensification on the DIL with preservation of the prostatic urethra, would lead to a higher probability of local control without a significant increase in toxicity compared to standard clinical practice.
This is a prospective single-arm phase II study designed to evaluate the effectiveness, safety and impact on quality of life of focal dose intensification using SBRT technology and extreme hypofractionated radiotherapy.
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
- •Histologically confirmed adenocarcinoma of the prostate
- •Primary localized PCa, cN0 and cM0, intermediate or high-risk disease according to NCCN 2023
- •Signed written informed consent for this study
- •T2-T3a clinical stage with visible DIL on mpMRI
- •Desirable prostate volume (not mandatory) < 80 cc or > 80 cc if urinary function is preserved and dosimetrically feasible
- •IPSS ≤ 18 (International Prostate Symptom Score)
排除标准
- •Unresolved previous prostatitis, symptomatic urethral stenosis
- •Bilateral hip prosthesis
- •T3b-4 clinical stage or N1
- •M1 (presence of distant metastases)
- •Previous surgery at the prostate level (Transurethral Resection of the Prostate) within the last 6 months
结局指标
主要结局
Local control
时间窗: 12 months
Disappearance of suspicious image on mpMRI.
Biochemical progression-free survival
时间窗: 3 years
Biochemical progression as Phoenix definition (PSA nadir +2 ng/ml)
次要结局
- Incidence and severity of late urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale(2 years)
- Incidence and severity of acute rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale(90 days)
- Incidence and severity of acute urinary treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale(90 days)
- Incidence and severity of late rectal treatment-related adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale(2 years)
- Patient reported outcomes and quality of life assessment(2 years)
研究者
Almudena Zapatero
Principal Investigator and Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa