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Prostate CancerNCT07245745

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

A study testing Radiotherapy in people with Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteBelgium
Study dates
13 Jan 2026to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Heylen Sofie, MD contact

027648191

sofie.heylen@saintluc.uclouvain.be

Van Ooteghem Geneviève, MD contact

027644763

genevieve.vanooteghem@saintluc.uclouvain.be

Belgium1 site, 1 recruiting

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

    Heylen Sofie, MD, +3227648191, sofie.heylen@saintluc.uclouvain.be

    Van Ooteghem Geneviève, MD, +3227644763, genevieve.vanooteghem@saintluc.uclouvain.be

    Recruiting

Other trials in Belgium

About this study

Official title: Prospective Clinical Study Comparing Patient-reported Outcomes Measurements (PROMS) After Adaptive or Conventional Radiotherapy in Prostate Cancer

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
Being tested
Radiotherapy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    Prostate cancer patients will be treated radiotherapy.

Study groups in NCT07245745
Study groupRoleWhat they receive
Arm H-RTActive comparatorTreatment planned and delivered on the Halcyon machine with non-adaptive conventional radiotherapy.
Receives: Radiation: Radiotherapy
Arm E-ARTActive comparatorTreatment planned and delivered on the Ethos machine with adaptive radiotherapy.
Receives: Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 years

Secondary outcomes (4)

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

    This study will collect PROMs and clinical data to assess whether the duration of adverse effects before recovery differs between the two radiotherapy approaches (adaptive versus conventional).

    Measured: 3 years

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

    The duration of adverse effects before recovery may also be correlated with dosimetric analyses. Indeed, ART could allow better dose coverage of the target volumes while reducing the dose delivered to the OARs. The Ethos system enables monitoring of the accumulated dose to both targets and OARs, thereby allowing complementary dosimetric analyses.

    Measured: 3 years

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

    Since patients will complete PROMs questionnaires through an e-health application, this will allow a qualitative analysis of the application. Specific questions will be asked to patients regarding their use of the application.

    Measured: 3 years

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

    This study could thus highlight a novel approach to managing patient toxicity and assess whether it could improve overall treatment management.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2025
  2. Study start13 Jan 2026
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
188 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07245745
Sponsor's protocol ID
2025/27MAI/209
Status last verified
Sep 2025
First submitted
22 Sep 2025
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 15989996

  • 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.

    PubMed 17241751

  • 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.

    PubMed 9015813

  • 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.

    PubMed 30928061

  • 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.

    PubMed 34846098

  • 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.

    PubMed 27055486

  • 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.

    PubMed 34923034

  • 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.

    PubMed 35144569

Questions about this trial

What is this clinical trial studying?

A study testing Radiotherapy in people with Prostate Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heylen Sofie, MD (027648191, sofie.heylen@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstration that adaptive radiotherapy in prostate cancer helps reduce radiotherapy-induced side effects (digestive, urinary, and general toxicity) using PROMS questionnaires. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07245745, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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