Clinical trial · Observational
PRO-MR-RT Systematic Patient-reported Outcomes to Pelvic Online MRgRT
PRO-MR-RT Systematic Web-based Patient-reported Outcomes for a Personalized, Patient-centered Symptom Management and Clinical Assessment of Pelvic Toxicity to Magnetic Resonance Radiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In 2018 the Unity MR-linac was approved for treating patients with online magnetic resonance (MR)-guided radiotherapy. With the MR-linac it is possible to get real-time MR images with high soft tissue contrast, adapt the radiotherapy plan and subsequently irradiate at each treatment fraction. Patients with prostate cancer is one of the patient groups referred for this new treatment and potentially they will benefit with decreased margins around the tumour and increased local tumor control rates. The acute toxicity is important when evaluating treatment tolerability. A prospective longitudinal observation of the acute treatment toxicity to online MR-guided radiotherapy is therefore essential in the evaluation of this new technology. Patient-reported outcomes (PRO) are disease symptoms and treatment toxicity reported directly by patients themselves without clinician interpretation. Several studies have indicated that clinicians tend to underreport the incidence and severity of patient symptoms, thus a systematic use of PROs in clinical trials can provide valuable evidence to the clinicians. As online MR-guided radiotherapy (MRgRT) is a new technology there is limited research worldwide on patient-reported symptoms and quality of life. The objective of this study is therefore to prospectively investigate the patient-reported acute toxicity and changes in quality of life during and after online MR-guided radiotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-guided radiotherapy | Radiation | — | UNRESOLVED |
| Online MR-guided radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Online MR-guided radiotherapy
- description
- Prostate cancer patients treated with online MR-guided radiotherapy in the Unity MR-linac.
- interventionNames
- Radiation: Online MR-guided radiotherapy
- label
- CT-guided radiotherapy
- description
- Prostate cancer patients treated with CT-guided radiotherapy (VMAT) in linear accerelators.
- interventionNames
- Radiation: CT-guided radiotherapy
Primary outcomes (1)
- measure
- ACUTE TOXICITY
- timeFrame
- During or up to six months following radiotherapy completion.
- description
- Mean change in acute urinary and bowel toxicity when treated with MR-guided radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients diagnosed with cancer in the prostate * referred for primary radiotherapy or salvage radiotherapy Exclusion Criteria: * Cognitively unable to provide informed consent * Unable ro read, understand and complete patient-reported surveys in Danish (electronic or paper-based)
References
Publications (0)
Data not yet available