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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07245745

2025/27MAI/209

Details and patient eligibility

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).

Enrollment: 188 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

188 participants in 2 patient groups

Arm H-RT

Active Comparator group

Description:

Treatment planned and delivered on the Halcyon machine with non-adaptive conventional radiotherapy.

Treatment:

Radiation: Radiotherapy

Arm E-ART

Active Comparator group

Description:

Treatment planned and delivered on the Ethos machine with adaptive radiotherapy.

Treatment:

Radiation: Radiotherapy