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NCT Number: NCT03326440

Virtual Environment Radiotherapy 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.

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VERT system

Other

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)

Primary outcomes

  1. Volume of bladder measurement in cm3

    Time frame: Through study completion, an average of seven and a half weeks.

    Measuring the bladder volume during Radiotherapy to assess if offering visual information to patients with prostate cancer prior to receiving radiotherapy increases their compliance.

Secondary outcomes

  1. Does increased compliance translate into reduced side effects from RT.

    Time frame: Through study completion and follow up - an average of 8 months

    Data collection regarding radiotherapy side effects will be collected throughout the radiotherapy sessions and for 6 months after the radiotherapy

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

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

Acronym: VERT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 31, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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