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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615909
• Other study ID #: OP_775
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Background:

In 2018 the first patients worldwide were treated with the first 1.5 T MR-linac. The MR-linac is innovative technology in cancer treatment making precision radiotherapy possible, as it is a linear accelerator mounted on a ring around a 1.5-Tesla MRI Scanner combined with an online adaptive radiotherapy planning system. When the patient is positioned in 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. The improved visualization on the MR images makes it possible to see how the tumour and the organs around it changes and adapt the treatment plan every day. This opens up for a reduction of safety margins needed to insure target coverage and increased use of hypo- fractionation. Cancer patients will hopefully benefit from this with decreased treatment toxicity and increased local tumor control rates.

Today, computed tomography (CT)-guided intensity-modulated radiotherapy is standard treatment for patients with pelvic or abdominal tumors. However, the visualization of the tumor and surrounding tissue is poor due to low soft-tissue contrast in the cone-beam scans. When using MRI for online radiotherapy planning in pelvic and abdominal sites, the soft-tissue contrast will be high making it possible to improve contouring accuracy and reduce margins. The potential of the MR-linac lowering treatment toxicity can greatly impact survivorship and quality of life. This would particularly be beneficial for patients diagnosed with cancer in the pelvic region, like prostate cancer, having considerably high chances of survival.

The standard for toxicity monitoring in cancer clinical trials is the prospective clinician reporting of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). CTCAE grading, as well as patient-reported outcomes (PRO), is also part of the proposed standard assessment methodology for clinical evaluation of radiotherapy innovations like online MRgRT. Several studies have identified discrepancies between clinician and patient reporting within systemic treatment where clinicians appear to underreport the severity of treatment toxicity, compared to patient-reported severity. Therefore, patient self-reports are an important supplement to the evaluation of online MRgRT as in other oncological settings where they have been used as direct indicators of worsening, persistence or improvement of symptoms and general well-being. Furthermore, patient self-reports reduces the risk of unanticipated treatment toxicities being undetected.

Methods:

Study Design:

The study is a prospective single-arm longitudinal observational study including all prostate cancer patients treated with online MR-guided radiotherapy or CT-guided radiotherapy in the study period.

Participants:

Patients with prostate cancer referred for radiotherapy at Odense University Hospital in the time period 15.11.2020 - 01.07.2022 will be eligible for inclusion.

Data collection:

A patient pathway app, My Hospital, will be used for data collection. A PRO item set for patients with prostate cancer has been developed and tested in a pilot study (PRO-CTCAE and EORTC items). The item set will be used weekly during treatment and 4 weeks following to capture expected and unanticipated symptoms of acute treatment toxicity. During follow-up patients wll be asked to report 8, 12 and 24 weeks after radiotherapy completion. Other questionnaires will be used to measure quality of life (EORTC QLQ-C30+EORTC PR25), health-related quality of life (EQ-5D-5L), patient experience with ePRO (Patient Feedback Form) and patient experience with treatment on a 1.5 T Unity MR-linac (Patient Experience Questionnaire).

Data on clinician management of PROs will be drafted from the patient app My Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).
• 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)

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	AgeCare Academy of Geriatric Cancer Research, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACUTE TOXICITY - increased urinary frequency	A two-level increase from baseline in the PRO-CTACE item urinary frequency scored on a 5-point likert scale (0 being abscence of symptom, 4 being highest frequency) for minimum two consecutive symptom-reports.	During or up to six months following radiotherapy completion.
Secondary	QUALITY OF LIFE (QoL) change after CT-guided or online MR-guided radiotherapy	Mean change in QoL from baseline to follow-up week 12. Measured with the questionnaires EORTC QLQ-C30 and Euroqol EQ-5D-5L.	QoL and HRQoL will be reported at baseline (before radiotherapy) and 12 weeks after radiotherapy completion.
Secondary	EXPERIENCE	The patients are to report how weekly ePROs with real-time feedback in their course of radiotherapy impact their involvement, the quality of care and communication with clinicians. Patient satisfaction is measured with questions from the validated Patient Feedback Form on a 4-point likert scale (strongly agree, agree, disagree, strongly disagree).	Patient experience will be measured one week following radiotherapy completion.
Secondary	ACUTE TOXICITY	A pelvic item set developed and tested in a pilot study is used to capture symptomatic adverse events (AEs). This item set includes PRO-CTCAE items (5-point likert scale, 0 being absence of symptoms) and EORTC items (4-point likert scale, 1 being absence of symptoms). Median number of weeks to first maximum worsening of the adverse events are measured. Persistence of symptoms is measured as being > baseline score until 12 weeks following radiotherapy.	Symptoms are reported weekly during treatment and in the four weeks following radiotherapy completion. Patient reporting of acute AEs during follow-up at week 8 and 12 after radiotherapy completion.
Secondary	EXPERIENCE	Patient experience with online MR-guided radiotherapy will be measured with a questionnaire specifically developed and validated to capture patient experience in a MR-linac (4-point likert scale).The questionnaire will also be tested on patients undergoing CT-guided radiotherapy to descriptively look at the differences in the two cohorts.	The patients will be asked to report their experience in the last week of radiotherapy.

External Links

•   Pilot study conducted before this prospective longitudinal study