Prospective Clinical Study Comparing PROMS After Adaptive or Conventional Radiotherapy in Prostate Cancer

March 12, 2026 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Prospective Clinical Study Comparing Patient-reported Outcomes Measurements (PROMS) After Adaptive or Conventional Radiotherapy in Prostate Cancer

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm H-RT
Treatment planned and delivered on the Halcyon machine with non-adaptive conventional radiotherapy.
Radiation: Radiotherapy
Prostate cancer patients will be treated radiotherapy.
Active Comparator: Arm E-ART
Treatment planned and delivered on the Ethos machine with adaptive radiotherapy.
Radiation: Radiotherapy
Prostate cancer patients will be treated radiotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: 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).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires.
Time Frame: 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).
3 years
Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data.
Time Frame: 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.
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.
Time Frame: 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.
3 years
Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire.
Time Frame: 3 years
This study could thus highlight a novel approach to managing patient toxicity and assess whether it could improve overall treatment management.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Heylen Sofie, MD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

September 22, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/27MAI/209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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