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This prospective clinical study compares patient-reported outcome measures (PROMs) after adaptive or conventional radiotherapy in prostate cancer. Adaptive radiotherapy (ART) aims to reduce uncertainties related to daily anatomical variations, thereby improving treatment accuracy while decreasing gastrointestinal (GI) and genitourinary (GU) toxicity. This study, conducted at Cliniques universitaires Saint-Luc (Brussels and Ottignies sites), analyzes and compares toxicities in patients treated with ART on Ethos and those treated with conventional radiotherapy on Halcyon.
The primary objective of the study is to demonstrate that ART reduces gastrointestinal, urinary, and general side effects induced by radiotherapy. Additionally, the secondary objectives include assessing the duration of these effects, correlating them with dosimetric data, analyzing the management of toxicities through the Noona e-health application, as well as evaluating the use of this application by both patients and healthcare providers.
The study includes men aged 18 years or older with prostate cancer undergoing curative-intent treatment, with an ECOG performance status of 0 to 1, and able to use the Noona application. Patients with a history of rectal or bladder treatment, or those who have already received pelvic radiotherapy, are excluded. Two groups are compared: patients treated with conventional radiotherapy on Halcyon (Ottignies site) and those treated with adaptive radiotherapy on Ethos (Brussels site).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm H-RT | Active Comparator | Treatment planned and delivered on the Halcyon machine with non-adaptive conventional radiotherapy. |
|
| Arm E-ART | Active Comparator | Treatment planned and delivered on the Ethos machine with adaptive radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Prostate cancer patients will be treated radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires. | In this clinical study, we aim to demonstrate that adaptive radiotherapy (ART) in prostate cancer can reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity). Daily adaptation of treatment plans not only ensures better target coverage but also accounts for daily variations in the position or deformation of organs at risk (OARs). Consequently, ART could reduce the occurrence of genitourinary (GU) and gastrointestinal (GI) side effects, either early (during or shortly after treatment) or at later stages (up to one year after completion of treatment). Three questionnaires will be used: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), the EuroQol 5 Dimensions (EQ-5D) and the International Prostate Symptom Score (IPSS). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires. | This study will collect PROMs and clinical data to assess whether the duration of adverse effects before recovery differs between the two radiotherapy approaches (adaptive versus conventional). | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heylen Sofie, MD | Contact | 027648191 | sofie.heylen@saintluc.uclouvain.be | |
| Van Ooteghem Geneviève, MD | Contact | 027644763 | genevieve.vanooteghem@saintluc.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Heylen Sofie, MD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15989996 | Background | de Crevoisier R, Tucker SL, Dong L, Mohan R, Cheung R, Cox JD, Kuban DA. Increased risk of biochemical and local failure in patients with distended rectum on the planning CT for prostate cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):965-73. doi: 10.1016/j.ijrobp.2004.11.032. | |
| 17241751 | Background |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data. |
The duration of adverse effects before recovery may also be correlated with dosimetric analyses. Indeed, ART could allow better dose coverage of the target volumes while reducing the dose delivered to the OARs. The Ethos system enables monitoring of the accumulated dose to both targets and OARs, thereby allowing complementary dosimetric analyses. |
| 3 years |
| Evaluation of the management of treatment-related toxicity using the e-health application using a PREM questionnaire at the end of the study. | Since patients will complete PROMs questionnaires through an e-health application, this will allow a qualitative analysis of the application. Specific questions will be asked to patients regarding their use of the application. | 3 years |
| Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire. | This study could thus highlight a novel approach to managing patient toxicity and assess whether it could improve overall treatment management. | 3 years |
| Heemsbergen WD, Hoogeman MS, Witte MG, Peeters ST, Incrocci L, Lebesque JV. Increased risk of biochemical and clinical failure for prostate patients with a large rectum at radiotherapy planning: results from the Dutch trial of 68 GY versus 78 Gy. Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1418-24. doi: 10.1016/j.ijrobp.2006.11.014. Epub 2007 Jan 22. |
| 9015813 | Background | Yan D, Vicini F, Wong J, Martinez A. Adaptive radiation therapy. Phys Med Biol. 1997 Jan;42(1):123-32. doi: 10.1088/0031-9155/42/1/008. |
| 30928061 | Background | Posiewnik M, Piotrowski T. A review of cone-beam CT applications for adaptive radiotherapy of prostate cancer. Phys Med. 2019 Mar;59:13-21. doi: 10.1016/j.ejmp.2019.02.014. Epub 2019 Feb 22. |
| 34846098 | Background | Byrne M, Archibald-Heeren B, Hu Y, Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J, Collett N, Aland T. Varian ethos online adaptive radiotherapy for prostate cancer: Early results of contouring accuracy, treatment plan quality, and treatment time. J Appl Clin Med Phys. 2022 Jan;23(1):e13479. doi: 10.1002/acm2.13479. Epub 2021 Nov 29. |
| 27055486 | Background | Thornqvist S, Hysing LB, Tuomikoski L, Vestergaard A, Tanderup K, Muren LP, Heijmen BJ. Adaptive radiotherapy strategies for pelvic tumors - a systematic review of clinical implementations. Acta Oncol. 2016 Aug;55(8):943-58. doi: 10.3109/0284186X.2016.1156738. Epub 2016 Apr 8. |
| 34923034 | Background | Christiansen RL, Dysager L, Hansen CR, Jensen HR, Schytte T, Nyborg CJ, Bertelsen AS, Agergaard SN, Mahmood F, Hansen S, Hansen O, Brink C, Bernchou U. Online adaptive radiotherapy potentially reduces toxicity for high-risk prostate cancer treatment. Radiother Oncol. 2022 Feb;167:165-171. doi: 10.1016/j.radonc.2021.12.013. Epub 2021 Dec 16. |
| 35144569 | Background | Brunelli C, Zito E, Alfieri S, Borreani C, Roli A, Caraceni A, Apolone G. Knowledge, use and attitudes of healthcare professionals towards patient-reported outcome measures (PROMs) at a comprehensive cancer center. BMC Cancer. 2022 Feb 10;22(1):161. doi: 10.1186/s12885-022-09269-x. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |