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

Free University of Brussels (ULB)

Status: Completed

Conditions: Radiotherapy Side Effect; Quality of Life; Prostate Cancer; Bowel Dysfunction

Treatments: Other: Bowel symptoms & QoL assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05880446

CE3650 (Other Identifier)

IJB-PROCAR-BQ-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Bowel symptoms & QoL assessment

Other group

Description:

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.

Treatment:

Other: Bowel symptoms & QoL assessment