- Design
- Multicentre randomised trial (5:4), open-label
- Population
- 700 men on androgen deprivation therapy for prostate cancer in 15 NHS trusts
- Primary outcome
- FACT-P and FACIT-F at 12 months
- Effect
- FACT-P +4.5 (97.232% CI 1.7 to 7.2); FACIT-F +1.9 (0.4 to 3.4)
STAMINA was a multicentre randomised trial across 15 NHS trusts in England. It allocated 700 men on androgen deprivation therapy for prostate cancer 5:4 to a 12-month programme or to optimised usual care. The programme combined supervised aerobic and resistance exercise, dietary advice, behavioural support and gym membership. Usual care included clinician training, educational materials, behavioural prompts and safety checks.
At 12 months the programme was better on cancer-specific quality of life (FACT-P adjusted mean difference 4.5, 97.232% CI 1.7 to 7.2; p=0.0004) and fatigue (FACIT-F 1.9, 0.4 to 3.4; p=0.0068). Three serious adverse events occurred in the intervention group, all recovered, and there were no treatment-related deaths.
Participants knew their allocation, outcomes were self-reported, and 97% of participants were White, with outcome data missing for 11% to 19%. The programme needs supervised sessions and gym access, which will be difficult in many settings. Structured exercise advice during hormone therapy, even home-based, remains a reasonable aim.
- Offer supervised or structured exercise to men on androgen deprivation therapy where available.
- Quality of life and fatigue improved at 12 months compared with optimised usual care.
- Screen for safety before starting exercise, as the trial did.
- Resources are the limit; adapt with home-based resistance and aerobic activity if supervised programmes are unavailable.
Why it matters
It shows that guideline-recommended exercise can be delivered inside routine cancer care and produce measurable benefit.
Don't overread it
Open-label with self-reported outcomes, mostly White participants, and a resource-intensive programme; cancer outcomes were not studied.
The statistics, in plain English
A 4.5-point difference in a quality-of-life scale is statistically clear; whether it feels meaningful depends on the scale's minimal important difference, which the abstract does not state. Open-label trials with self-reported outcomes can overstate benefit.
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