Patient reported outcomes (PRO) of patients treated with Proton therapy for Prostate cancer: A prospective registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. Toxicity assessment
研究概览
简要总结
| Background and Rationale |
Proton therapy by virtue of its unique physical characteristics enables delivery of high dose of radiation to tumours with significantly lower doses to adjacent healthy normal tissues compared to contemporary photon external beam radiotherapy techniques. Several dosimetry comparison have shown reduction in dose to adjacent healthy normal tissues namely the bladder and rectum with proton beam therapy .This dosimetric advantage can be leveraged to potentially reduce the incidence and severity of acute and late toxicities associated with prostate cancer radiotherapy . Considering recent availability of proton therapy in this part of world and upcoming proton facilities, it is important to maintain data prospectively of all prostate cancer patients treated using proton beam therapy. It is also necessary to explore benefits of proton beam therapy in various clinical scenarios such as definitive, postoperative and re-irradiation. In addition, to explore the benefits of proton therapy with different fractionation schemes such as conventional, moderately hypo-fractionated and extreme hypo-fractionated regimens. This formulates basis for our proposal of prospective proton therapy registry trial. In addition we propose to collect pre and post radiation treatment quality of life assessment of all patients, at baseline and on every follow up who are enrolled in this study using QOL tool.
|General aim
The general aim of this study is to establish a prospective and standardized database (or "registry") of prostate patients treated with radiation therapy at the Apollo Proton Cancer Centre.
|Primary objective (endpoint)
· Toxicity assessment [ Time Frame – 0 to 5 years]
Acute/late toxicity according to RTOG toxicity scale
|Secondary objectives (endpoints)
· Overall survival (OS) for patients [ Time Frame – 0 to 5 years]
· Biochemical progression free survival (bPFS) for all patients [ Time Frame – 0 to 5 years]
· Distant metastases free survival (DMFS) for all patients [Time Frame – 0 to 5 years]
· Patient-reported quality of life for all patients using EORTC QLQ-C30 and PR-25 questionnaires
|Design
Observational registry
|Population
All prostate cancer patients treated with proton therapy at the Apollo Proton Cancer Centre who consent to have their health information recorded.
|Statistical considerations
Descriptive statistical analysis will be applied to routine demographic data collected, expressed as frequency for categorical variables. Chi-square test and Fisher’s exact test was used for comparisons. Kaplan Meir curves will be used to summarize the time to event endpoints over time. Log-rank test will be used to test for differences in the OS for dichotomous variables. Factors significant in the univariate analysis will be tested by multivariate analysis using the Cox proportional hazard model.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Male
入选标准
- •Age more than 18 years
- •Patient with biopsy proven diagnosis of prostate cancer treated with proton beam at the Apollo Proton Cancer Centre.
- •Patient / guardian, who have the ability to understand and be willing to sign a written informed consent document.
排除标准
- •Patients or legal guardians who are not willing sign informed consent document.
结局指标
主要结局
1. Toxicity assessment
时间窗: 1. Toxicity assessment | Assessment of acute (during treatment and upto 6 weeks after completion of treatment), subacute (Post treatment 6 weeks to 6 months) and late (6 months to 5 years post treatment) toxicities using RTOG acute/late toxicity criteria.
Assessment of acute (during treatment and upto 6 weeks after completion of treatment), subacute (Post treatment 6 weeks to 6 months) and late (6 months to 5 years post treatment) toxicities using RTOG acute/late toxicity criteria.
时间窗: 1. Toxicity assessment | Assessment of acute (during treatment and upto 6 weeks after completion of treatment), subacute (Post treatment 6 weeks to 6 months) and late (6 months to 5 years post treatment) toxicities using RTOG acute/late toxicity criteria.
次要结局
- Quality of Life (QOL) assessment of all prostate cancer patients treated with PBT using(EORTC QLQ PR-25 and EORTC QLQ-C30 for all patients)
- Overall survival (OS) for patients(0,1,2,3,4,5 years)
- Biochemical progression free survival (bPFS) for all patients(0,1,2,3,4,5 years)
- Distant metastases free survival (DMFS) for all patients(0,1,2,3,4,5 years)