Clinical trial · Interventional
PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)
PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.
NCT05880446CI-TRIAL-00077078PROCAR-BQcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bowel Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bowel symptoms & QoL assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bowel symptoms & QoL assessment
- 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.
- interventionNames
- Other: Bowel symptoms & QoL assessment
Primary outcomes (1)
- measure
- Mean Delta of EORTC Proctitis Module (PRT20) score
- timeFrame
- At study completion, an average of 4 months
- description
- 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 outcomes (1)
- measure
- Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDDelobel 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
- BACKGROUNDHeemsbergen 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
- BACKGROUNDAndreyev 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
- BACKGROUNDLawrie 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
- BACKGROUNDSini 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
- BACKGROUNDHalkett 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.