PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)

Study Overview
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Brief Summary
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This is a prospective pilot study to evaluate the mean increase of bowel symptoms after pelvic radiotherapy (RT) in prostate cancer (PCa) patient using the validated & newly translated EORTC-QLQ PRT20 module.

Detailed Description
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Questionnaires (QLQ-C30 and PRT20 modules) will be held to patients at the beginning and at the end of RT (4 weeks) to evaluate the mean increase of lower GI symptoms and decrease in overall QoL after pelvic RT. For exploratory objectives, GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis, a 24h recall and DQI-I calculation will be assessed by the PI before the start of RT. CT sim & dosimetry will be analyse by the PI before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoid and the rectum. A Polar watches will be loaned to the patient by the PI at the CT sim appointment to record patient's daily movement for two weeks (usual waiting time between CT and treatment) and recovered on the first day of treatment.

Official Title
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PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.

Conditions
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Prostate Cancer, Radiotherapy Side Effect, Bowel Dysfunction, Quality of Life

Intervention / Treatment
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* Other: Bowel symptoms & QoL assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men with PCa which are candidate for pelvic radiotherapy (RT) with or without previous surgery, with or without concomitant hormonotherapy (HT), Performance status (PS) 0-2 (all patient able to undergo RT treatment), of all age, elderly included. Exclusion Criteria: Previous RT to the pelvis Diagnosed Inflammatory Bowel Disease (IBD), celiac disease Severe GI symptoms before the beginning of RT (Grade > 2 according to CTCAE grading system) Obvious cognitive impairment, Inability to understand French/English and no contact person able to accompany and translate.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Quality of life questionnaires and dietician advice before and at the end of treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bowel symptoms & QoL assessment<br>This single arm study represent a group a patient with prostate cancer who are candidate for pelvic radiotherapy. Patient reported outcomes on bowel toxicity and overall quality of life will be systematically assessed right before and after RT. Various potential predictive factors will be analysed. | Other: Bowel symptoms & QoL assessment<br>* QoL and bowel symptoms questionnaires will be held to patients, anthropomorphic measurement, handgrip test, physical activity level and usual diet quality of the patient will be assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Delta of EORTC Proctitis Module (PRT20) score | Mean Delta between the end and the beginning of RT (4 weeks) in PRT20 score (Min 18, Max 72, higher scores mean worse outcome) | At study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score | Mean Delta between the end and the beginning of RT (4 weeks) in C30 score (For symptoms: Min 28, Max 112, higher scores mean worse outcome; For general status: Min 2, Max 14, higher scores mean better outcome) | At study completion, an average of 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Radiotherapy Side Effect, Radiation Toxicity, Bowel Dysfunction, Pelvic Radiation Disease, Diarrhea, Radiation Proctitis, Radiation enteritis, Quality of Life, Malnutrition, Sarcopenia, Diet, Physical activity