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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

Cognitive impairment

ECOG ≥ 2

History of treatment for rectal or bladder cancer

History of pelvic radiotherapy

Trial design

Treatments tested in this trial

  • Radiotherapy

Treatment groups

188 Participants
are divided into 2 treatment groups