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

NCT05880446 | Completed

• 2 other identifiers: IJB-PROCAR-BQ-2023CE3650
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score

  At study completion, an average of 4 months

Other Outcomes (6)

• Sarcopenia prevalence and its association with PRT20 and QLQ-C30 score Delta.

  At study completion, an average of 4 months

• Malnutrition prevalence and its association with PRT20 and QLQ-C30 score Delta.

  At study completion, an average of 4 months

• Max Dose on Bowel Bag, Sigmoid & Rectum and its association with PRT20 and QLQ-C30 score Delta.

  At study completion, an average of 4 months

Study Arms (1)

Bowel symptoms & QoL assessment

OTHER

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

Interventions

Bowel symptoms & QoL assessment OTHER

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.

Bowel symptoms & QoL assessment

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Anderlecht, Brussels Capital, 1070, Belgium

Location

Related Publications (6)

• Delobel JB, Gnep K, Ospina JD, Beckendorf V, Chira C, Zhu J, Bossi A, Messai T, Acosta O, Castelli J, de Crevoisier R. Nomogram to predict rectal toxicity following prostate cancer radiotherapy. PLoS One. 2017 Jun 22;12(6):e0179845. doi: 10.1371/journal.pone.0179845. eCollection 2017.

  PMID: 28640871 BACKGROUND

• Heemsbergen WD, Peeters ST, Koper PC, Hoogeman MS, Lebesque JV. Acute and late gastrointestinal toxicity after radiotherapy in prostate cancer patients: consequential late damage. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):3-10. doi: 10.1016/j.ijrobp.2006.03.055. Epub 2006 Jul 11.

  PMID: 16814954 BACKGROUND

• Andreyev HJ, Benton BE, Lalji A, Norton C, Mohammed K, Gage H, Pennert K, Lindsay JO. Algorithm-based management of patients with gastrointestinal symptoms in patients after pelvic radiation treatment (ORBIT): a randomised controlled trial. Lancet. 2013 Dec 21;382(9910):2084-92. doi: 10.1016/S0140-6736(13)61648-7. Epub 2013 Sep 23.

  PMID: 24067488 BACKGROUND

• Lawrie TA, Green JT, Beresford M, Wedlake L, Burden S, Davidson SE, Lal S, Henson CC, Andreyev HJN. Interventions to reduce acute and late adverse gastrointestinal effects of pelvic radiotherapy for primary pelvic cancers. Cochrane Database Syst Rev. 2018 Jan 23;1(1):CD012529. doi: 10.1002/14651858.CD012529.pub2.

  PMID: 29360138 BACKGROUND

• Sini C, Noris Chiorda B, Gabriele P, Sanguineti G, Morlino S, Badenchini F, Cante D, Carillo V, Gaetano M, Giandini T, Landoni V, Maggio A, Perna L, Petrucci E, Sacco V, Valdagni R, Rancati T, Fiorino C, Cozzarini C. Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects. Radiother Oncol. 2017 Aug;124(2):296-301. doi: 10.1016/j.radonc.2017.07.005. Epub 2017 Jul 21.

  PMID: 28739383 BACKGROUND

• Halkett GKB, Wigley CA, Aoun SM, Portaluri M, Tramacere F, Livi L, Detti B, Arcangeli S, Lund JA, Kristensen A, McFadden N, Grun A, Bydder S, Sackerer I, Greimel E, Spry N; EORTC Quality of Life Group. International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study. Radiat Oncol. 2018 Aug 29;13(1):162. doi: 10.1186/s13014-018-1107-x.

  PMID: 30157890 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries; Intestinal Diseases; Diarrhea; Malnutrition; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 30, 2023
• Study Start: October 6, 2023
• Primary Completion: March 29, 2024
• Study Completion: March 29, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)