Prostate CancerPROCAR-BQNCT05880446
PROstate CAncer Radiotherapy - Bowel Quality of Life (PROCAR-BQ)
A study testing Bowel symptoms & QoL assessment in people with Prostate Cancer and Radiotherapy Side Effect, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Radiotherapy Side Effect, Bowel Dysfunction
- What is being tested?
- Bowel symptoms & QoL assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Oct 2023to 29 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.
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.
Read the 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.
- Being tested
- Bowel symptoms & QoL assessment
- 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
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries, Intestinal Diseases, Diarrhea, Malnutrition, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowel symptoms & QoL assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bowel symptoms & QoL assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At study completion, an average of 4 months
Secondary outcomes (1)
Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score
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)
Measured: At study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start6 Oct 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quality of life questionnaires and dietician advice before and at the end of treatment.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline De Bruyn, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880446
- Sponsor's protocol ID
- IJB-PROCAR-BQ-2023
- Other IDs
- CE3650
- Acronym
- PROCAR-BQ
- Status last verified
- May 2024
- First submitted
- 10 May 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28640871Heemsbergen 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.
PubMed 16814954Andreyev 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.
PubMed 24067488Lawrie 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.
PubMed 29360138Sini 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.
PubMed 28739383Halkett 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.
PubMed 30157890
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROstate CAncer Radiotherapy: Its Real Impact on Bowel Symptoms & Quality of Life Today, Measured by the EORTC QLQ C30 & Specific PRT20 Module.
- ClinicalTrials.gov ID
- NCT05880446
- Acronym / sponsor ID
- PROCAR-BQ / IJB-PROCAR-BQ-2023
- Keywords
- Prostate Cancer, Radiotherapy Side Effect, Radiation Toxicity, Bowel Dysfunction, Pelvic Radiation Disease, Diarrhea, Radiation Proctitis, Radiation enteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quality of life questionnaires and dietician advice before and at the end of treatment.
| Arm | Type | Receives |
|---|---|---|
| Bowel symptoms & QoL assessment | Other | Other: Bowel symptoms & QoL assessmentThis 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel symptoms & QoL assessmentQoL 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. | Other | Bowel symptoms & QoL assessment |
Primary outcome
Mean Delta of EORTC Proctitis Module (PRT20) score
Time frame: 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)
1 secondary outcome
Mean Delta of EORTC Quality of Life Questionnaire (QLQ-C30) score
Time frame: At study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 28640871Delobel 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.
- Background: PubMed 16814954Heemsbergen 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.
- Background: PubMed 24067488Andreyev 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.
- Background: PubMed 29360138Lawrie 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.
- Background: PubMed 28739383Sini 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.
- Background: PubMed 30157890Halkett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowel symptoms & QoL assessment in people with Prostate Cancer and Radiotherapy Side Effect, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Delta of EORTC Proctitis Module (PRT20) score (time frame: At study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05880446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.