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Completed NCT05615909

PRO-MR-RT Systematic Patient-reported Outcomes to Pelvic Online MRgRT

Conditions: Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Enrollment: 156
Sponsor: Odense University Hospital

Location: Denmark

Summary

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.

Eligibility Criteria

Inclusion Criteria:patients diagnosed with cancer in the prostatereferred for primary radiotherapy or salvage radiotherapyExclusion Criteria:Cognitively unable to provide informed consentUnable ro read, understand and complete patient-reported surveys in Danish (electronic or paper-based)

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05615909). StuddyBuddy aggregates publicly available trial information.