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.