Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA)

Supported Exercise TrAining for Men wIth prostate caNcer on androgen deprivation therapy (STAMINA) is an integrated lifestyle intervention embedding supervised exercise and dietary advice into routine care pathways (1):

• androgen deprivation therapy (ADT) causes significant adverse effects in men with prostate cancer, including negative impacts on cancer-specific quality of life and fatigue in up to 77% of patients
• despite national (NICE) and international (EAU) guideline recommendations supporting supervised exercise, structured lifestyle interventions are rarely integrated into routine primary or secondary care pathways
• phase 3 multicentre evidence demonstrates that the STAMINA intervention significantly improves cancer-specific quality of life and reduces fatigue compared with optimised usual care

Mechanism of Action and Intervention Structure

• integrated clinical referral pathway: treating clinical teams identify eligible patients and prescribe the intervention directly within standard cancer care pathways
• supervised exercise prescription: delivered in community fitness centres by upskilled personal trainers, combining aerobic and resistance exercise tailored to individual capability
• session frequency and duration: twice-weekly supervised sessions for 13 weeks (1:1 transitioning to small groups), followed by negotiated monthly-to-quarterly supervision over 12 months total, supported by complimentary gym membership and dietary advice

Key Trial Findings (STAMINA Study)

• study design: multicentre, randomised superiority trial across 15 UK NHS trusts in England comparing the STAMINA lifestyle intervention (n = 389) with Optimised Usual Care (n = 311) over 12 months
• study population: 700 men on or starting ADT for prostate cancer (median age 71.6 years; 34% metastatic disease; 19% receiving concurrent chemotherapy or novel androgen receptor pathway inhibitors)
• cancer-specific quality of life (co-primary endpoint; FACT-P total score at 12 months):
  • STAMINA lifestyle intervention demonstrated statistically significant superiority over Optimised Usual Care (adjusted mean difference 4.5 points, 97.232% CI 1.7 to 7.2; p = 0.0004)
• fatigue mitigation (co-primary endpoint; FACIT-F subscale at 12 months):
  • STAMINA lifestyle intervention demonstrated statistically significant reduction in fatigue compared with Optimised Usual Care (adjusted mean difference 1.9 points, 97.232% CI 0.4 to 3.4; p = 0.0068)
• secondary quality-of-life and physical activity endpoints:
  • FACT-G total score: significant benefit exceeding the minimal clinically important difference threshold (adjusted mean difference 3.7 points; p < 0.0001)
  • subscale improvements: statistically significant benefits maintained across physical, social/family, emotional, and functional wellbeing subscales
  • EQ-5D health utility: significantly higher utility scores at 3, 6, and 12 months (p <= 0.0022 across all timepoints)
  • physical activity: higher self-reported leisure-time exercise (Godin scale) sustained at 12 months (p = 0.0036)
• cost-effectiveness:
  • incremental cost-effectiveness ratio (ICER) of £13,920 to £19,077 per QALY gained, falling well below standard NHS funding thresholds (£25,000–£30,000 per QALY) with >70% to 80% probability of cost-effectiveness

Adverse Effects and Safety Profile

• intervention-related serious adverse events: rare (n = 3 in intervention group: transient loss of consciousness, leg pain/weakness, back pain), with full recovery in all cases
• treatment-related mortality: zero treatment-related deaths recorded

Primary Care Takeaways

• proactive symptom recognition: fatigue and quality-of-life decline are major sources of morbidity in men on ADT; primary care clinicians should recognize these as treatable toxicities rather than unavoidable disease progression
• structured supervised exercise over simple advice: written leaflets or informal verbal advice alone are insufficient; structured, supervised programs combining aerobic and resistance training provide necessary behavioral reinforcement
• safety in multi-morbid patients: supervised exercise is safe for men on ADT, including those with common baseline comorbidities like hypertension, osteoarthritis, and musculoskeletal complaints (73% of trial participants had >= 2 comorbidities)
• primary care signposting and advocacy: GPs and practice nurses should actively direct patients to local integrated exercise-on-prescription schemes or cancer rehabilitation services and reinforce long-term adherence during routine reviews

Reference:

• Bourke L, Rosario DJ, Reale S, et al. An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial. Lancet Oncol. 2026;27(10):1283-1294.