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

NCT05615909 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2024-08-19

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Online MR-guided radiotherapy

Online adaptive MR-guided radiotherapy in the Unity MR-linac for localized intermediate risk prostate cancer (60 Gy/20 fx) or low-volume metastatic prostate cancer (36 Gy/6 fx).

RADIATION

CT-guided radiotherapy

CT-guided radiotherapy in linear accelerators for patients with high-risk prostate cancer (78 Gy/39 fx), intermediate risk prostata cancer (60 Gy/20 Fx) or having salvage radiotherapy (70 Gy/35 fx)

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • AgeCare Academy of Geriatric Cancer Research

    collaborator UNKNOWN

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Pia KK Møller, MPH · Research Unit of Oncology, Odense University Hospital

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2023-06-30
Completion
2023-12-31

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05615909 on ClinicalTrials.gov