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

Sponsor

Jules Bordet Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05880446

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Radiotherapy Side Effect Bowel Dysfunction Quality of Life	Other: Bowel symptoms & QoL assessment	N/A

Detailed Description

Questionaires (QLQ-C30 and PRT20 modules) will be held to patients at the beginning and at the end of RT (4weeks) to evaluate the mean increase of lower GI symptoms and descrease in overal QoL after pelvic RT.

For exploratory objectives, GLIM measures for malnutrition diagnosis will be assessed by the PI at the beginning and at the end of RT, CT simulation & dosimetry will be analyze by the PI before treatment to evaluation the body composition and the max and mean dose received by the bowel, the sigmoïde and the rectum and the quality of the patient diet will be assessed by the dietician at the beginning of the RT by the mean of a 24h-recall and DQI-I calculation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Quality of life questionnaires and dietician advice before and at the end of treatment.Quality of life questionnaires and dietician advice before and at the end of treatment.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	Other: Bowel symptoms & QoL assessment QoL and bowel symptoms questionnaires will be held to patients, anthropomorphic measurement, handgrip test and usual diet quality of the patient will be assessed.

Arm

Intervention/Treatment

Other: 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.

Other: Bowel symptoms & QoL assessment

QoL and bowel symptoms questionnaires will be held to patients, anthropomorphic measurement, handgrip test and usual diet quality of the patient will be assessed.

Outcome Measures

Primary Outcome Measures

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

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)

Other Outcome Measures

Sarcopenia incidence [At last patient included starting RT treatment, an average of 3 months]
Men with L3 skeletal muscle index < 52.4 cm2/m2 will be classified as having sarcopenia. Skeletal muscle cross-sectional area in cm2 at the third lumbar vertebra will be measured on the CT simulation (2 weeks before RT start) then normalized for stature to report the L3 skeletal muscle index in cm2/m2. Hand-grip strength will be assessed as supportive measure the same day.
Malnutrition incidence [At last patient included starting RT treatment, an average of 3 months]
Analysis of GLIM (Global Leadership Initiative on Malnutrition) criteria for malnutrition diagnosis. One of the tree positive phenotypic criteria will lead to positive diagnosis of malnutrition: >5 % weight loss within past 6 months (asked to patient during visit or compared to previous reports), BMI < 20-22 (weight and height will be combined to report BMI in kg/m^2), Reduces muscle mass by L3 skeletal muscle index < 52.4 cm2/m2 (skeletal muscle cross-sectional area in cm2 at the third lumbar vertebra will be measured by CT then normalized for stature to report the L3 skeletal muscle index in cm2/m2)
Max Dose on Bowel Bag, Sigmoïde & Rectum & its association with PRT20 score [At study completion, an average of 4 months]
Descriptive analysis of individual Dmax in Gy on BowelBag, Sigmoïde & Rectum on RT plan dosimetry and individual PRT20 score at the end of RT
Mean Dose on Bowel Bag, Sigmoïde & Rectum & its association with PRT20 score [At study completion, an average of 4 months]
Descriptive analysis of Dmean in Gy on BowelBag, Sigmoïde & Rectum on RT plan dosimetry and individual PRT20 score at the end of RT
Diet Quality Index & its association with PRT20 score [At study completion, an average of 4 months]
Diet Quality Index (DQI-I) will be calculated from analysis of patient usual diet by the mean of a 24-h recall method (2 week days, 1 week-end day) before the start of RT and by it's conversion in nutritional values using composition tables. The continuous measure of the total DQI-I scores (Min 0, Max 100) of each patient will be categorized into quartiles (Very low, Low, Intermediate, High) and correlated to individual PRT20 score at the end of RT in a descriptive manner.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts 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), 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 symptoms before the beginning of RT
Cognitive impairment,
Inability to understand French/English and no contact person able to accompany and translate.