The STAMINA (Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy) programme, funded by the NIHR, includes the largest randomised clinical trial in prostate cancer and exercise worldwide.
The £4m project explores the clinical and cost-effectiveness of embedding supervised exercise into the NHS prostate cancer care pathway. It is delivered in partnership with Sheffield Teaching Hospitals NHS Foundation Trust, Nuffield Health and the Clinical Trials Research Unit at the Leeds Institute for Clinical Trials Research.
To date, 1,656 referrals from 16 NHS Trusts have been processed by the team at Sheffield Hallam University with the final 700th patient recruited this month.
Dr Liam Bourke, Professor of Cancer Research at Sheffield Hallam University, said: “This is a fantastic achievement from a superb team of researchers. We are very grateful to the NHS for its engagement and the brilliant support we have had from Nuffield Health over the years. A huge thank you also goes to every single patient who has agreed to take part. We simply can’t do this kind of work without such support.”
Professor Derek Rosario, Programme Chief Investigator, Honorary Professor at SHU and Consultant Urological Surgeon at Sheffield Teaching Hospitals NHS Foundation Trust, said: “This is a magnificent team achievement, made possible thanks to our many partners: the NHS prostate cancer clinical teams, the research staff at NHS sites and their patients. We are also extremely proud that the research has been delivered to a very high standard, not least because this has been achieved during a time of unprecedented pressure on clinical research activity. We are looking forward to the results with great anticipation.”
Professor Ben Kelly, Director of Data at Nuffield Health, said: "We all know that physical activity is crucial for staying fit and healthy, and for supporting our mental well-being. However, the benefits of exercise are often overlooked when it comes to the management of long-term health conditions. At Nuffield Health we are committed to building the health of the nation, and we are proud to be a key partner in STAMINA, which will provide incredibly valuable, real-world insight into the role supported exercise has in the management of men on ADT therapy. Today marks an important milestone in the programme, and this takes us another step towards a better evidence base in this area."
Professor Amanda Farrin, Programme methodological lead and Professor of Clinical Trials and Evaluation of Complex Interventions at the University of Leeds, said: “Here at the Clinical Trials Research Unit at the University of Leeds, we are delighted to be part of the team designing and delivering this important trial, which will deliver high-quality evidence aiming to improve the lives of men living with prostate cancer. Achieving this significant milestone with 700 men recruited to the trial is a testament to the hard work from all in the research team across Sheffield and Leeds, as well as staff at the NHS sites and their patients.”
Historian, broadcaster and filmmaker Professor David Olusoga OBE joined the STAMINA team at the University this month to discuss the project and offer congratulations on achieving the patient milestone.
Professor David Olusoga OBE said: "Prostate cancer affects lots of people and it’s great to see that trials like STAMINA are working so hard to get the best outcomes for NHS patients."
Androgen deprivation therapy (ADT), a standard treatment for prostate cancer, is associated with significant side effects, including fatigue, depression, sexual dysfunction, cognitive dysfunction (impairment of memory and concentration), increased fat mass and loss of muscle strength. ADT also increases the risk of developing bone fractures, diabetes and heart and circulatory problems. Currently, the only evidence-based treatment to offset the side effects of ADT is via supervised exercise and dietary modification.
The STAMINA pathway of care sees urology and oncology departments recommend exercise to men with prostate cancer in routine clinic appointments and refer men with prostate cancer on ADT to the programme. Patients cannot currently self-refer.
The team at Sheffield Hallam carry out safety checks and tailoring of the intervention before referring men to specifically trained clinical exercise specialists at Nuffield Health. The STAMINA-trained individuals are responsible for delivering the behaviourally-informed STAMINA lifestyle intervention, including one-to-one and small-group supervised programmes tailored to individuals.
If successful, the project could provide a blueprint which can be applied to other cancer and health conditions where exercise has been found to be beneficial.
The results of the STAMINA study are anticipated in early 2025.
