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

Condition(s) studied

Investigational drug(s) / intervention(s)

Radiotherapy: Prostate cancer patients will be treated radiotherapy.

Study summary

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

Primary outcome measure(s)

• Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires. — 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).

Trial sites (1)

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