Exercise during androgen deprivation therapy works, when somebody is paid to deliver it

Design

Multicentre, randomised, open-label trial across 15 NHS trusts in England (ISRCTN46385239)

Population

700 men on androgen deprivation therapy for prostate cancer; median age 71.6 years, 97% White

Primary outcome

FACT-P quality of life and FACIT-F fatigue at 12 months, by intention to treat

Effect

FACT-P adjusted mean difference 4.5 (97.2% CI 1.7-7.2), p=0.0004; FACIT-F 1.9 (0.4-3.4), p=0.0068

Every prostate cancer guideline recommends supervised exercise during androgen deprivation therapy, and almost nobody delivers it. STAMINA tested whether building it into the service changes that, randomising 700 men on androgen deprivation therapy across 15 NHS trusts in England 5:4 to a 12-month programme of supervised aerobic and resistance exercise, dietary advice, behavioural support and gym membership, or to optimised usual care - which was not nothing: it included clinician training, educational materials, behavioural prompts and safety-to-exercise checks.

At 12 months the intervention was superior on both primary outcomes. Cancer-specific quality of life on FACT-P improved by an adjusted mean of 4.5 points (97.2% CI 1.7-7.2, p=0.0004) and fatigue on FACIT-F by 1.9 points (0.4-3.4, p=0.0068). Three serious adverse events were attributed to the intervention - a transient loss of consciousness, leg pain or weakness, and back pain - and all three men recovered. No treatment-related deaths.

Two caveats matter. The differences are modest in absolute terms, and the trial does not tell us whether they clear a threshold a patient would notice. And the cohort was 97% White with a median age of 71.6 in a state-funded system with gym infrastructure - the intervention itself, not just the exercise, is what was tested, and it is the part that does not travel.

What does travel is the design principle. The comparator here already had trained clinicians and written advice, and it still lost to supervised delivery. So advising a man on androgen deprivation therapy to exercise is demonstrably weaker than arranging it. Where a supervised programme is not fundable - which is most Indian practice - the honest reading is that the referral, the check and the follow-up appointment are doing the work, not the leaflet.

• Do the safety-to-exercise check yourself: bone metastases, cardiac history, neuropathy, anaemia
• Refer to a supervised programme where one exists rather than advising exercise in the abstract
• Combine resistance with aerobic work - the trial tested both, not one
• Book a review that asks specifically about fatigue, not just PSA and testosterone
• Where no programme exists, set a specific, written weekly plan and follow it up at the next visit

The statistics, in plain English

An adjusted mean difference of 4.5 points on FACT-P is a group average, not what any individual gained - some men will have improved considerably and others not at all. The trial does not state whether 4.5 points exceeds the smallest difference a patient would notice, so read it as a real but modest effect. The unusual 97.232% confidence interval is a correction for testing two primary outcomes; it is wider than a conventional 95% interval, so the result is if anything more conservative than it looks. Participants knew their allocation, which matters when the outcomes are self-reported questionnaires.

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