Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07245745

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

Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2026-03-16

188

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with prostate cancer referred for curative-intent radiotherapy
  • Male patients 18 years or older
  • ECOG performance status 0 or 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
Not Eligible

You will not qualify if you...

  • Cognitive impairment
  • ECOG performance status 2 or higher
  • History of treatment for rectal or bladder cancer
  • History of pelvic radiotherapy
  • No access to the Noona application on a smartphone or computer

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cliniques universitaires Saint-Luc

Brussels, Belgium, 1200

Actively Recruiting

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Research Team

H

Heylen Sofie, MD

CONTACT

V

Van Ooteghem Geneviève, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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