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

Not Applicable

Completed

• Conditions: Bowel Dysfunction; Radiotherapy Side Effect; Quality of Life; Prostate Cancer
• Interventions: Other: Bowel symptoms & QoL assessment

• Registration Number: NCT05880446
• Lead Sponsor: Jules Bordet Institute

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-19
• Study First Posted: 2023-05-30
• Study Start: 2023-10-06
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bowel symptoms & QoL assessment	Bowel symptoms & QoL assessment	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score	At study completion, an average of 4 months	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)

Trial Locations

Locations (1)

Institut Jules Bordet; 🇧🇪 Anderlecht, Bruxelles, Belgium