Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07245745

Prospective Clinical Study Comparing 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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

Prostate cancer patients will be treated radiotherapy.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heylen Sofie, MD

CONTACT

[email protected]

027648191

Van Ooteghem Geneviève, MD

CONTACT

[email protected]

027644763

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.