JMIR Publications

ABSTRACT

Background:

Despite improvements in radiation techniques, pelvic radiotherapy is responsible for acute and delayed bladder adverse events, defined as radiation cystitis (RCC). The first symptoms of bladder injury secondary to pelvic irradiation are likely to occur during treatment or within 3 months of radiotherapy in about 50% of irradiated patients and have a significant impact on their quality of life. The pathophysiology of CysR is not well understood, particularly because of the risk of complications associated with access to bladder tissue after irradiation, which limits our ability to study this process and develop treatments.

Objective:

The main objective of our study is to evaluate the correlation of biological biomarkers with the intensity of acute CysR and the quality of life of patients, assessed with the digital telemonitoring platform Cureety.

Methods:

Patients with intermediate-risk localised prostate cancer eligible for localised radiotherapy will be included. Inflammatory biomarkers will be analysed in urine and blood samples before the start of radiotherapy, at weeks 4, 12 and 48 of irradiation, by quantitative methods such as Multiplex Luminex, flow cytometry and enzyme-linked immunosorbent assay. We will also characterise the patient’s gut and urine microbiota composition using 16S rRNA sequencing technology. Between sample collection visits, patients will complete various questionnaires related to radiation cystitis symptoms (IPSS), adverse events and quality of life (FACT-P), using the Cureety digital remote monitoring platform.

Results:

Upon receipt of the questionnaires, an algorithm will process the information and classify patients according to the severity of symptoms and adverse events reported according to CTCAE / IPSS standards. This will allow us to correlate levels of urinary, blood and faecal biomarkers with the severity of acute CysR symptoms and patient-reported quality of life.

Conclusions:

This prospective study is the first to explore the overexpression of inflammatory proteins in fluid biopsies from patients with symptoms of acute CysR. In addition, the one-year follow-up after treatment will allow us to predict which patients are at risk of late CysR and to refer them for radioprotective treatment. The results of this study will allow us to develop strategies to limit radiation damage to the bladder and improve the quality of life of patients. Clinical Trial: NCT05246774