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

Prostate Carcinoma Clinical Trial

— VERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326440
• Other study ID #: 772
• Status: Completed
• Phase: N/A
• Start date: October 8, 2015
• Est. completion date: May 31, 2018

Study information

• Verified date: October 2019
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

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)

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands, Royal Stoke University Hospital, City General Site, Newcaslte Road	Stoke on Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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