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An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial
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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·September 4Open Access
OncologyPractice changingProstate CancerRandomized Controlled TrialAndrogen Deprivation TherapyExercise And Lifestyle InterventionOlder Adult

Summary

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What was studied

The STAMINA trial evaluated whether a 12-month supervised aerobic and resistance exercise programme combined with dietary advice, behavioural support, and gym membership (vs. Optimised Usual Care) improved cancer-specific quality of life and fatigue in men on androgen deprivation therapy (ADT) for prostate cancer across 15 NHS trusts in England.

Key findings

STAMINA lifestyle intervention was superior to Optimised Usual Care at 12 months: FACT-P improved by an adjusted mean difference of 4.5 points (97.232% CI 1.7–7.2; p=0.0004) and FACIT-F by 1.9 points (0.4–3.4; p=0.0068). Three serious adverse events occurred in the intervention group (all resolved); no treatment-related deaths.

Study limitations

- 97% of participants were White, limiting generalisability to more diverse populations. - Participants were aware of treatment allocation (open-label), introducing performance bias risk. - Optimised Usual Care was an active comparator (not a true no-intervention control), which may underestimate absolute benefit of supervised exercise.

Clinical implications

Men on ADT for prostate cancer should be offered a structured supervised exercise and dietary advice programme: the STAMINA intervention produced meaningful improvements in quality of life and fatigue with a low serious adverse event rate. Clinicians now have a clear, guideline-aligned model to prescribe and integrate this intervention into routine NHS cancer care.

Caveats

  • All enrolled participants were male by design; findings are not applicable to other populations.
  • The confidence interval is reported as '97.232% CI' rather than the conventional 95% CI — this unusual threshold appears intentional (likely Bonferroni-adjusted for dual primary outcomes) but may cause confusion when comparing effect sizes to other trials.
  • The FACT-P minimally important clinical difference threshold is not stated in the abstract; clinicians should interpret the 4.5-point improvement in that context.

Related Questions

Explore related topics

What supervised exercise programmes are recommended for men on androgen deprivation therapy?How does exercise affect fatigue and quality of life in prostate cancer patients on ADT?What are the best strategies to manage ADT side effects in prostate cancer?

Publication Details

Year
2026
Journal
The Lancet Oncology
Sample Size
n=700
Source
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