Adaptive versus conventional radiotherapy: comparing patient-reported side effects for prostate cancer
Prospective Clinical Study Comparing Patient-reported Outcomes Measurements (PROMS) After Adaptive or Conventional Radiotherapy in Prostate Cancer
This study tests whether adaptive radiotherapy causes fewer bowel, bladder, and overall side effects than conventional radiotherapy in men receiving curative treatment for prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07245745 on ClinicalTrials.gov |
What this trial studies
This prospective study compares patient-reported outcome measures (PROMs) after adaptive radiotherapy (ART) delivered on the Ethos platform versus conventional radiotherapy on the Halcyon platform for prostate cancer. Participants complete regular PROMs and toxicity reporting via the Noona e-health application to capture gastrointestinal, genitourinary, and general side effects and their duration. The trial also correlates reported symptoms with dosimetric data to see if differences in delivered dose to organs at risk explain clinical outcomes. Patients are enrolled at Cliniques universitaires Saint‑Luc (Brussels and Ottignies) and must be able and willing to use the Noona app during and after treatment.
Who should consider this trial
Good fit: Men with prostate cancer referred for curative-intent radiotherapy who are age 18 or older, ECOG 0-1, proficient in French, English, or Dutch, and able and willing to use the Noona e-health app are ideal candidates.
Not a fit: Patients with prior pelvic radiotherapy, prior treatment for rectal or bladder cancer, cognitive impairment, or no access/ability to use the Noona app are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, ART could reduce the frequency and duration of bowel and urinary side effects from prostate radiotherapy, improving patients' quality of life.
How similar studies have performed: Early feasibility and dosimetric studies of adaptive radiotherapy have shown reduced dose to organs at risk and suggested possible toxicity reductions, but randomized or definitive evidence in prostate cancer remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Heylen Sofie, MD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Heylen Sofie, MD
- Email: sofie.heylen@saintluc.uclouvain.be
- Phone: 027648191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.