Trial reportThe Lancet. Oncology2026
An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial.
Trial report in The Lancet. Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Defining benefit from lifestyle interventions during active surveillance.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
Corrections and comments
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Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAndrogen deprivation therapy (ADT) for prostate cancer causes substantial adverse effects. Despite consistent national and international guideline recommendations, supervised exercise is rarely integrated into care. We aimed to determine whether the STAMINA lifestyle intervention, embedded into cancer care, would improve cancer-specific quality of life and fatigue versus behaviourally Optimised Usual Care in men with prostate cancer in England.
methodsSTAMINA was a multicentre, randomised trial done across 15 UK National Health Service (NHS) trusts in England. Men on ADT for prostate cancer were eligible. Participants were randomly assigned (5:4) via computer-generated minimisation, stratified by age, ADT duration, chemotherapy or androgen receptor pathway inhibitor therapy, and radiotherapy, to the STAMINA lifestyle intervention or to Optimised Usual Care. Participants were aware of treatment allocation. The STAMINA lifestyle intervention comprised supervised aerobic and resistance exercise for 12 months, dietary advice, behavioural support, and complimentary gym membership. Optimised Usual Care comprised clinician training, educational materials, behavioural prompts, and safety-to-exercise checks. Primary outcomes were the Functional Assessment of Cancer Therapy-prostate (FACT-P) and the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale at 12 months, analysed by intention to treat (according to randomised treatment). This trial is registered with ISRCTN (ISRCTN46385239), and recruitment is complete.
findingsBetween Jan 20, 2022, and June 12, 2023, 700 men were randomly assigned to STAMINA lifestyle intervention (n=389) or Optimised Usual Care (n=311). Median age was 71·6 years (IQR 66·3-76·0), and 680 (97%) of 700 participants were White. Primary outcome data were available for 345 (89%) of 389 participants in the STAMINA lifestyle intervention group and 251 (81%) of 311 in the Optimised Usual Care group. The STAMINA lifestyle intervention was superior to Optimised Usual Care in terms of FACT-P score (adjusted mean difference 4·5, 97·232% CI 1·7-7·2; p=0·0004) and FACIT-F score (1·9, 0·4-3·4; p=0·0068). Three intervention-related serious adverse events occurred in the STAMINA lifestyle intervention group (transient loss of consciousness, leg pain or weakness, and back pain); all participants recovered. No treatment-related deaths occurred.
interpretationThe STAMINA lifestyle intervention meets best practice guidelines, can be implemented in NHS trusts in England, and offers clinicians a clear basis for identification and prescription of a supervised exercise and dietary advice intervention to mitigate negative effects associated with ADT.
fundingNational Institute for Health Research.
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