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

NCT07245745 | Recruiting

• 1 other identifier: 2025/27MAI/209
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

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

  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).

  3 years

Secondary Outcomes (4)

• Evaluation of the time to recovery from treatment-related adverse effects using PROMS questionnaires.

  3 years

• Correlation of the duration of adverse effects collected with PROMS questionnaire with the dosimetric data.

  3 years

• Evaluation of the management of treatment-related toxicity using the e-health application using a PREM questionnaire at the end of the study.

  3 years

• Number of participants and medical staff satisfied by the ease of use of an e-health application during radiotherapy using a questionnaire.

  3 years

Study Arms (2)

Arm H-RT

ACTIVE COMPARATOR

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

Radiation: Radiotherapy

Arm E-ART

ACTIVE COMPARATOR

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

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Prostate cancer patients will be treated radiotherapy.

Arm E-ART; Arm H-RT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (8)

• de Crevoisier R, Tucker SL, Dong L, Mohan R, Cheung R, Cox JD, Kuban DA. Increased risk of biochemical and local failure in patients with distended rectum on the planning CT for prostate cancer radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Jul 15;62(4):965-73. doi: 10.1016/j.ijrobp.2004.11.032.

  PMID: 15989996 BACKGROUND

• Heemsbergen WD, Hoogeman MS, Witte MG, Peeters ST, Incrocci L, Lebesque JV. Increased risk of biochemical and clinical failure for prostate patients with a large rectum at radiotherapy planning: results from the Dutch trial of 68 GY versus 78 Gy. Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1418-24. doi: 10.1016/j.ijrobp.2006.11.014. Epub 2007 Jan 22.

  PMID: 17241751 BACKGROUND

• Yan D, Vicini F, Wong J, Martinez A. Adaptive radiation therapy. Phys Med Biol. 1997 Jan;42(1):123-32. doi: 10.1088/0031-9155/42/1/008.

  PMID: 9015813 BACKGROUND

• Posiewnik M, Piotrowski T. A review of cone-beam CT applications for adaptive radiotherapy of prostate cancer. Phys Med. 2019 Mar;59:13-21. doi: 10.1016/j.ejmp.2019.02.014. Epub 2019 Feb 22.

  PMID: 30928061 BACKGROUND

• Byrne M, Archibald-Heeren B, Hu Y, Teh A, Beserminji R, Cai E, Liu G, Yates A, Rijken J, Collett N, Aland T. Varian ethos online adaptive radiotherapy for prostate cancer: Early results of contouring accuracy, treatment plan quality, and treatment time. J Appl Clin Med Phys. 2022 Jan;23(1):e13479. doi: 10.1002/acm2.13479. Epub 2021 Nov 29.

  PMID: 34846098 BACKGROUND

• Thornqvist S, Hysing LB, Tuomikoski L, Vestergaard A, Tanderup K, Muren LP, Heijmen BJ. Adaptive radiotherapy strategies for pelvic tumors - a systematic review of clinical implementations. Acta Oncol. 2016 Aug;55(8):943-58. doi: 10.3109/0284186X.2016.1156738. Epub 2016 Apr 8.

  PMID: 27055486 BACKGROUND

• Christiansen RL, Dysager L, Hansen CR, Jensen HR, Schytte T, Nyborg CJ, Bertelsen AS, Agergaard SN, Mahmood F, Hansen S, Hansen O, Brink C, Bernchou U. Online adaptive radiotherapy potentially reduces toxicity for high-risk prostate cancer treatment. Radiother Oncol. 2022 Feb;167:165-171. doi: 10.1016/j.radonc.2021.12.013. Epub 2021 Dec 16.

  PMID: 34923034 BACKGROUND

• Brunelli C, Zito E, Alfieri S, Borreani C, Roli A, Caraceni A, Apolone G. Knowledge, use and attitudes of healthcare professionals towards patient-reported outcome measures (PROMs) at a comprehensive cancer center. BMC Cancer. 2022 Feb 10;22(1):161. doi: 10.1186/s12885-022-09269-x.

  PMID: 35144569 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Heylen Sofie, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heylen Sofie, MD

CONTACT

027648191; sofie.heylen@saintluc.uclouvain.be

Van Ooteghem Geneviève, MD

CONTACT

027644763; genevieve.vanooteghem@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: November 24, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 16, 2026

Record last verified: 2025-09

Locations

BE (1)