An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial.
L. Bourke, Derek Rosario, et al. • The Lancet Oncology • 2026
The STAMINA lifestyle intervention was superior to Optimised Usual Care in terms of cancer-specific quality of life (FACT-P) and fatigue (FACIT-F) at 12 months in men receiving androgen deprivation therapy for prostate cancer.
Key Findings
Results
The STAMINA lifestyle intervention significantly improved cancer-specific quality of life compared to Optimised Usual Care at 12 months.
Primary outcome measured using the Functional Assessment of Cancer Therapy-prostate (FACT-P) scale
Adjusted mean difference of 4.5 (97.232% CI 1.7–7.2; p=0.0004) in favor of the STAMINA intervention
700 men were randomly assigned: 389 to STAMINA and 311 to Optimised Usual Care
Primary outcome data were available for 345 (89%) of 389 STAMINA participants and 251 (81%) of 311 Optimised Usual Care participants
Analysis was by intention to treat
Results
The STAMINA lifestyle intervention significantly reduced fatigue compared to Optimised Usual Care at 12 months.
Fatigue measured using the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale
Adjusted mean difference of 1.9 (97.232% CI 0.4–3.4; p=0.0068) in favor of the STAMINA intervention
Fatigue was a co-primary outcome alongside cancer-specific quality of life
Both primary outcomes were statistically significant
Results
The STAMINA lifestyle intervention was associated with a small number of intervention-related serious adverse events, with no treatment-related deaths.
Three intervention-related serious adverse events occurred in the STAMINA lifestyle intervention group
Events included transient loss of consciousness, leg pain or weakness, and back pain
All participants who experienced serious adverse events recovered
No treatment-related deaths occurred in either group
Methods
The trial enrolled 700 men on androgen deprivation therapy (ADT) for prostate cancer across 15 UK NHS trusts in England.
Recruitment took place between January 20, 2022, and June 12, 2023
Participants were randomly assigned in a 5:4 ratio (STAMINA:Optimised Usual Care) via computer-generated minimisation
Randomisation was stratified by age, ADT duration, chemotherapy or androgen receptor pathway inhibitor therapy, and radiotherapy
Median age was 71.6 years (IQR 66.3–76.0)
680 (97%) of 700 participants were White, indicating a homogeneous racial composition
Methods
The STAMINA lifestyle intervention comprised supervised aerobic and resistance exercise for 12 months, dietary advice, behavioural support, and complimentary gym membership.
The intervention was delivered over 12 months and embedded into cancer care
Optimised Usual Care comprised clinician training, educational materials, behavioural prompts, and safety-to-exercise checks
The intervention was implemented across 15 NHS trusts in England
Participants were aware of their treatment allocation (open-label design)
Background
Supervised exercise is rarely integrated into cancer care despite consistent national and international guideline recommendations.
ADT for prostate cancer causes substantial adverse effects
The STAMINA trial was designed to address the gap between guideline recommendations and clinical practice
The authors conclude the intervention 'meets best practice guidelines' and 'can be implemented in NHS trusts in England'
The intervention offers 'clinicians a clear basis for identification and prescription of a supervised exercise and dietary advice intervention to mitigate negative effects associated with ADT'
What This Means
This research suggests that men with prostate cancer who are receiving hormone therapy (called androgen deprivation therapy, or ADT) can experience meaningful improvements in their quality of life and fatigue levels if they participate in a structured lifestyle program. The STAMINA program included supervised aerobic and strength exercise over 12 months, dietary guidance, behavioral support, and free gym membership. In a trial involving 700 men across 15 hospitals in England, those who received the STAMINA intervention scored significantly better on standardized measures of cancer-specific quality of life and fatigue compared to men who received optimized usual care, which included educational materials and clinician training but not supervised exercise.
ADT is a common treatment for prostate cancer but is known to cause significant side effects, including fatigue, loss of muscle mass, weight gain, and reduced quality of life. Despite guidelines from national and international health bodies recommending supervised exercise for men on ADT, this type of support is rarely available in routine clinical practice. This study demonstrates that it is feasible to embed such a program into NHS care settings and that doing so produces measurable benefits for patients. The intervention was generally safe, with only three serious adverse events reported among nearly 400 participants, all of whom recovered.
This research suggests that structured, supervised exercise and dietary programs integrated into prostate cancer care could become a standard part of treatment for men on ADT. The findings provide a practical model for healthcare systems—particularly the UK NHS—to adopt lifestyle interventions that address the harmful side effects of hormone therapy, potentially improving the day-to-day lives of a large number of prostate cancer patients.
Check Your Own Numbers
Upload your bloodwork. We'll cross-reference your results against this study and 4,700 others.
L. Bourke, Derek Rosario, Sophie Reale, Saïd Ibeggazene, A. Innes, A. Scope, et al.. (2026). An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial.. The Lancet Oncology. https://doi.org/10.1016/S1470-2045(26)00304-9