Structured Lifestyle Program Mitigates Side Effects of Prostate Cancer Hormone Therapy

Androgen deprivation therapy (ADT) for prostate cancer causes substantial adverse effects. Although clinical guidelines consistently recommend supervised exercise for prostate cancer patients undergoing hormone therapy, it is rarely integrated into standard care.

To address this clinical gap, researchers conducted a multicentre, randomised trial to determine whether the STAMINA lifestyle intervention, embedded into cancer care, would improve cancer-specific quality of life and fatigue compared with behaviourally Optimised Usual Care in men with prostate cancer in England. The findings of the trial were published in The Lancet Oncology in September 2026.

Study Design and Patient Population

The STAMINA trial was a multicentre, randomised trial conducted across 15 UK National Health Service (NHS) trusts in England. Eligible participants were men on ADT for prostate cancer. Between January 20, 2022, and June 12, 2023, the study randomly assigned 700 men. The participants had a median age of 71.6 years (interquartile range 66.3 to 76.0), and 680 (97%) of the 700 participants were White. The trial is registered with the ISRCTN registry under the identifier ISRCTN46385239, and recruitment is complete.

Participants were randomly assigned in a 5:4 ratio to either the STAMINA lifestyle intervention group (389 men) or the Optimised Usual Care group (311 men). The random assignment was completed via computer-generated minimisation. The study stratified randomisation by several factors: participant age, duration of androgen deprivation therapy, use of chemotherapy or androgen receptor pathway inhibitor therapy, and use of radiotherapy. The trial was open-label; participants were aware of their assigned treatment allocation.

Intervention Versus Optimised Usual Care

The active STAMINA lifestyle intervention group received a 12-month program. This program comprised supervised aerobic and resistance exercise, dietary advice, behavioural support, and a complimentary gym membership.

In contrast, the control group received Optimised Usual Care. This comparator group's care comprised clinician training, educational materials, behavioural prompts, and safety-to-exercise checks.

Primary Outcomes and Quantitative Results

The primary outcomes of the STAMINA trial were measured using two clinical instruments: the Functional Assessment of Cancer Therapy-prostate (FACT-P) score and the Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale at 12 months. The primary analysis was performed using the intention-to-treat principle, evaluating participants according to their randomised treatment. These outcomes evaluated quality of life and fatigue at the 12-month mark.

Primary outcome data at 12 months were available for 345 (89%) of the 389 participants randomised to the STAMINA lifestyle intervention group and 251 (81%) of the 311 participants assigned to the Optimised Usual Care group.

At 12 months, the lifestyle program was superior to Optimised Usual Care in terms of both FACT-P and FACIT-F scores.

For the cancer-specific quality of life assessment, the STAMINA lifestyle intervention was superior to Optimised Usual Care, with an adjusted mean difference of 4.5 in the FACT-P score (97.232% CI 1.7-7.2; p=0.0004).

For the fatigue assessment, the adjusted mean difference between the groups in the FACIT-F score was 1.9 (0.4-3.4; p=0.0068).

Safety and Adverse Events

During the 12-month study, three intervention-related serious adverse events occurred within the STAMINA lifestyle intervention group. These serious adverse events consisted of transient loss of consciousness, leg pain or weakness, and back pain. All affected participants recovered. No treatment-related deaths occurred during the trial.

Implementation and Interpretations

According to the study's interpretation, the 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 androgen deprivation therapy.

The STAMINA trial was funded by the National Institute for Health Research.