Virtual Environment Radiotherapy to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer (VERT)

Virtual Environment Radiotherapy (VERT) to Improve Patients' Compliance to Radiotherapy (RT) in Prostate Cancer

Purpose of the study

1. To assess whether offering visual information to patients with prostate cancer prior to receiving RT increases the participant's compliance.
2. To assess whether increased compliance translates into reduced side effects from RT (assessed with a quality of life questionnaire).

Type of study. This is a randomised control trial which will include 170 patients with the histological diagnosis of prostate cancer in the study arm and 170 patients with the histological diagnosis of prostate cancer in the control/standard arm.

Study Overview

• Status: Completed
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: VERT system

Detailed Description

The Oncology Department at the Royal Stoke University Hospital is a state of the art facility. It has radiotherapy (RT) facilities such as IMRT and rapid arc, leading the way in RT planning and delivery. The Investigators want to further their expertise and public involvement in RT planning with this proposal.

This study follows a pilot study in which patients receiving RT were shown how treatment is planned and given using a 3 dimensional (3D) imaging system. It was noticed that patients with prostate cancer entering the pilot study might have been more compliant (holding water before each treatment session) than those with prostate cancer not entering the study. On this basis, the investigators wish to run this project in which prostate cancer patients will be shown how RT is planned and given using 3D images prior to start RT (study arm, 170 patients) or after completion of RT (control/standard arm, 170 patients). A sample size calculation was performed (see below) in order to distinguish a 10% improvement in retention of bladder volume over the course of treatment.

RT planning will be carried out using standard procedures at the Oncology Department. However, each study patient's CT Scan image will be placed in the Virtual Environment for Radiotherapy Training (VERT) system. The original images will not be altered and will be presented using the established JImage Dicom libraries. 3D models will be constructed from the CT Images. The system allows moving the 3D images using a mouse. Planning CT Scans will be taken prior to RT, on the first 3 days, and once weekly during RT to measure bladder volumes (this is standard practice and no patients will have extra CT Scans). The investigators will assess whether patients in the study arm were more compliant in holding water when compared to control cases.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST4 6QG
      • University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Patients with the histological diagnosis of prostate cancer due to receive radical RT.
• Patients with prostate cancer deemed fit enough to complete a course of radical RT to their prostate area.
• Patients able to give informed consent.

Exclusion Criteria:

• The only exclusion criteria is for participants unable to understand the study aims and therefore unable to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Study Arm; Patients with a histological diagnosis of prostate cancer are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system prior to the start of Radiotherapy.	Other: VERT system; 3D images of radiotherapy planning and administration using the VERT (Virtual Environment Radiotherapy) system is shown either prior to Radiotherapy (study arm) or post Radiotherapy (control arm)
Other: Control Arm; Patients with a histological diagnosis of prostate cancer who are shown how Radiotherapy is planned and given using 3D images on the VERT (Virtual Environment Radiotherapy) system following completion of Radiotherapy.	Other: VERT system; 3D images of radiotherapy planning and administration using the VERT (Virtual Environment Radiotherapy) system is shown either prior to Radiotherapy (study arm) or post Radiotherapy (control arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of bladder measurement in cm3	Measuring the bladder volume during Radiotherapy to assess if offering visual information to patients with prostate cancer prior to receiving radiotherapy increases their compliance.	Through study completion, an average of seven and a half weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does increased compliance translate into reduced side effects from RT.	Data collection regarding radiotherapy side effects will be collected throughout the radiotherapy sessions and for 6 months after the radiotherapy	Through study completion and follow up - an average of 8 months

Collaborators and Investigators

• Sponsor: University Hospitals of North Midlands NHS Trust
• Investigators: Principal Investigator: Josep Sule-Suso, University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Oncology Department, City General Site, Newcastle Road, Stoke on Trent, ST4 6QG

Study record dates

Study Major Dates

• Study Start: October 8, 2015
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO