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NCT07245745Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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).

Status (registry)
Recruiting
Study type
Interventional
Enrollment
188 (estimated)
First submitted
22 Sept 2025
Start date
13 Jan 2026
Primary completion date
31 Mar 2029
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
NCT number
NCT07245745

What you commit to

  • Study type: Interventional
  • Planned participants: 188
  • From 13 Jan 2026 to the primary completion date, 31 Mar 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cognitive impairment
  • History of treatment for rectal or bladder cancer
  • History of pelvic radiotherapy

Other

  • ECOG ≥ 2
  • No access to the Noona application on a smartphone or computer

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cliniques universitaires Saint-Luc
Coordinator of this site? Confirm its status
BrusselsBelgiumRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.