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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT07245745

Run by

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

People needed

188

Starts

2026-01-13

Expected to finish

2029-03-31

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cliniques universitaires Saint-Luc — Brussels, Belgium (enrolling)

Full record on ClinicalTrials.gov

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