For the roughly half-million men globally living under androgen deprivation therapy (ADT) for prostate cancer, the side-effect burden — fatigue, muscle loss, metabolic disruption, diminished quality of life — is relentless. Exercise has long been championed as a countermeasure, yet whether embedding a comprehensive supervised program into NHS care actually outperforms a well-designed usual care protocol remained an open and important clinical question. STAMINA provides the most rigorous answer to date.
The STAMINA trial enrolled men with prostate cancer on ADT across 15 NHS trusts in England, randomising them in a 5:4 ratio to either a 12-month integrated lifestyle intervention — encompassing supervised aerobic and resistance exercise, dietary guidance, behavioural support, and complimentary gym access — or to Optimised Usual Care, itself an active comparator involving clinician training, educational materials, behavioural prompts, and safety-to-exercise screening. Primary endpoints were prostate cancer-specific quality of life (FACT-P) and fatigue (FACIT-F subscale) at 12 months, analysed by intention to treat.
The result — a null finding between arms on both co-primary outcomes — carries nuanced implications. This is not evidence that exercise is ineffective for ADT-related toxicity; a substantial body of prior research, including multiple meta-analyses, confirms meaningful benefits from supervised exercise in this population. What STAMINA reveals instead is that a rigorously constructed usual-care comparator, one that equips both clinicians and patients with behavioural tools and exercise safety guidance, may itself mobilise enough physical activity to close the gap. This comparator inflation problem is increasingly recognised in behavioural intervention trials and complicates the interpretation of genuinely resource-intensive programs. Crucially, the open-label design and patient awareness of allocation may have influenced self-reported outcomes, and long-term follow-up data — particularly on cardiovascular, bone, and metabolic endpoints — are not yet available. For health systems, the finding suggests that lower-cost, scalable behavioural support frameworks may deliver comparable short-term patient-reported benefits to supervised gym-based programs, though this conclusion warrants cautious replication before reshaping service delivery.