About this trial
Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life.
There is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation.
The aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines.
The trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio.
Adherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.
Eligibility criteria
Qualifiers
Age > 18 at randomisation
Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment
If already started ADT, have received no more than eight weeks ADT at randomisation
Planned for radiotherapy
Disqualifiers
Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy
New symptoms of angina
New or unstable heart failure
Newly diagnosed diabetes that is not controlled
Trial design
Treatments tested in this trial
- Participation in a digital exercise intervention with virtual supervised group exercise sessions
Treatment groups
Sponsors and collaborators
Royal Marsden NHS Foundation Trust
Lead sponsor
King's College London
Collaborator