Prostate Cancer
Conditions
Brief summary
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).
Interventions
RADIATIONRadiotherapy
Prostate cancer patients will be treated radiotherapy.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with prostate cancer referred for curative-intent radiotherapy * Male patients ≥ 18 years old * ECOG performance status 0-1 * Patients willing to use an e-health application * Patients capable of using an e-health application * Proficient in French, English, or Dutch * No prior history of treatment for rectal or bladder cancer * No prior history of pelvic radiotherapy
Exclusion criteria
* Cognitive impairment * ECOG ≥ 2 * History of treatment for rectal or bladder cancer * History of pelvic radiotherapy * No access to the Noona application on a smartphone or computer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires. | 3 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires. | 3 years | 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). |
| Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data. | 3 years | 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. |
| Evaluation of the management of treatment-related toxicity using the e-health application using a PREM questionnaire at the end of the study. | 3 years | 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. |
| Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire. | 3 years | This study could thus highlight a novel approach to managing patient toxicity and assess whether it could improve overall treatment management. |
Countries
Belgium
Contacts
CONTACTHeylen Sofie, MD
CONTACTVan Ooteghem Geneviève, MD
PRINCIPAL_INVESTIGATORHeylen Sofie, MD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Outcome results
None listed