Prostate Carcinoma Clinical Trial
Official title:
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.
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.
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