A structured lifestyle intervention incorporating supervised exercise, dietary advice, and behavioral support helped mitigate deterioration in prostate cancer-specific quality of life and worsening fatigue among men receiving androgen deprivation therapy (ADT) for prostate cancer, according to results from the STAMINA randomized trial.
The study, titled “An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial,” was published online in The Lancet Oncology on September 4, 2026.
Authors: Liam Bourke, Derek J Rosario, Sophie Reale, Said Ibeggazene, Aidan Innes, Alison Scope, Grace Price, Steph Taylor, Liz Steed, Eileen Sutton, Jamie Stokes, Jenny Hewison, Dylan Morrissey, Patrick Doherty, Janet Brown, David Meads, John L O’Dwyer, Davina Deniszczyc, Diana M Greenfield, Malcolm Mason, Michelle Collinson, and Amanda Farrin, on behalf of the STAMINA investigators.
Why Was the STAMINA Trial Conducted?
ADT remains an important component of treatment for many men with prostate cancer, but it can have substantial adverse effects, including worsening fatigue and deterioration in cancer-specific quality of life.
Supervised exercise is recommended in national and international prostate cancer guidelines, yet it is rarely integrated into routine clinical care. Against this background, the investigators evaluated STAMINA as a lifestyle intervention embedded within prostate cancer care.
The trial assessed whether the STAMINA lifestyle intervention could improve cancer-specific quality of life and fatigue compared with behaviorally Optimised Usual Care in men receiving ADT for prostate cancer.
Study Design
STAMINA was a multicenter, randomized superiority trial conducted across 15 NHS trusts in England and registered as ISRCTN46385239. Men with prostate cancer who were already receiving ADT or were expected to start ADT within the following 12 weeks were eligible. Participants were randomly assigned in a 5:4 ratio to the STAMINA lifestyle intervention or Optimised Usual Care.
Randomization was stratified according to age, duration of ADT, receipt of chemotherapy or an androgen receptor pathway inhibitor, and receipt of radiotherapy.
The STAMINA intervention combined supervised aerobic and resistance exercise with dietary advice, behavioral support, and a complimentary 12-month gym membership. Exercise sessions were tailored to individual capability and initially delivered one-to-one before participants could move to small-group sessions.
Supervised exercise was delivered twice weekly for the first 13 weeks, followed by less frequent supervision negotiated between participants and clinical exercise specialists over the following 9 months. Optimised Usual Care was itself an active intervention. Clinical staff received training on exercise recommendations for men receiving ADT, while participants received educational materials, behavioral prompts, monitoring during routine clinical visits, and safety-to-exercise checks.
The two primary outcomes at 12 months were prostate cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and fatigue measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) subscale. Higher scores on both measures indicated better outcomes.
Patient Population
Between January 20, 2022, and June 12, 2023, 700 men were randomly assigned to treatment: 389 to STAMINA and 311 to Optimised Usual Care. The median age was 71.6 years, and 680 patients, or 97%, were White. More than half of participants had been receiving ADT for 12 weeks or less. Metastatic disease was documented in 239 patients, representing 34% of the study population, while 136 patients, or 19%, were receiving an androgen receptor pathway inhibitor or chemotherapy, or both.
Adherence to the exercise program was high. At least one supervised exercise session was delivered to 369 of 389 participants assigned to STAMINA, corresponding to 95% of the intervention group. The median number of supervised sessions attended was 28. Across 9,580 attended sessions, aerobic exercise was performed in 99% and resistance exercise in 97%.
STAMINA Mitigates Quality-of-Life Decline During ADT
At 12 months, questionnaires were returned by 345 of 389 participants in the STAMINA group and 251 of 311 participants in the Optimised Usual Care group. STAMINA was superior to Optimised Usual Care for both primary outcomes.
For FACT-P, the adjusted mean difference at 12 months was 4.5 points in favor of STAMINA (97.232% CI 1.7–7.2; p=0.0004). For FACIT-F, the adjusted mean difference was 1.9 points (97.232% CI 0.4–3.4; p=0.0068), also favoring STAMINA. Higher FACIT-F scores indicate lower levels of fatigue. Overall, STAMINA was superior to Optimised Usual Care in offsetting deterioration in prostate cancer-specific quality of life and fatigue over 12 months.
Several secondary quality-of-life outcomes also favored STAMINA. At 12 months, the adjusted mean difference in FACT-G was 3.7 points (97.232% CI 1.8–5.7; p<0.0001). The investigators noted that this exceeded the minimum clinically important difference threshold of more than 3 points.
Physical, social and family, emotional, and functional wellbeing scores also favored STAMINA at 12 months. However, there was no statistically significant difference in the prostate cancer-specific FACT-P subscale at that time point.
General health-related quality of life, assessed using EQ-5D, was also better with STAMINA throughout follow-up. At 12 months, adjusted mean EQ-5D scores were 0.79 with STAMINA versus 0.76 with Optimised Usual Care (p=0.0001).
Participants in the STAMINA group also reported greater leisure-time physical activity, with the between-group difference maintained at 12 months. No evidence of a difference was observed for fear of cancer recurrence, while physical outcomes were similar between the groups.
Safety
Thirteen deaths occurred during the trial, including six in the STAMINA group and seven in the Optimised Usual Care group. Three serious adverse events were considered related to the STAMINA intervention: transient loss of consciousness, leg pain or weakness, and back pain. All three participants recovered. No treatment-related deaths were reported.
Was STAMINA Cost-Effective?
An economic evaluation was conducted alongside the clinical trial. Using an assumed gym membership cost of £50 per month, the incremental cost-effectiveness ratio was £19,077 per quality-adjusted life-year gained. With an assumed monthly cost of £35, the corresponding estimate was £13,920 per QALY.
Both estimates were below the £25,000 per QALY threshold used by the investigators. Over the 12-month analysis, STAMINA had a greater than 70% probability of being cost-effective under the higher-cost scenario and a greater than 80% probability under the lower-cost scenario.
Study Limitations
Several limitations should be considered when interpreting the findings. The study population had limited ethnic diversity, with 97% of participants identifying as White. The investigators also noted a relatively high proportion of participants who rated themselves as physically fit at baseline. The prostate cancer treatment landscape also evolved during the trial. Only around one in five participants was receiving an androgen receptor pathway inhibitor or chemotherapy, although 34% of the overall population had metastatic disease.
Importantly, Optimised Usual Care was not a no-intervention control. It included clinician training, educational materials, behavioral prompts, and safety-to-exercise assessments and therefore represented an enhanced comparator that is not generally available in routine practice.
Dietary advice was included as part of STAMINA, but adherence to this component was not specifically measured. Missing outcome data were handled using multiple imputation, although sensitivity analyses produced results consistent with the primary analysis.
What Do the Findings Mean?
The STAMINA trial showed that a 12-month lifestyle intervention integrating supervised aerobic and resistance exercise, dietary advice, and behavioral support into prostate cancer care can better mitigate deterioration in prostate cancer-specific quality of life and worsening fatigue associated with ADT than an already enhanced usual-care approach.
The findings are particularly relevant because STAMINA was tested against an active comparator rather than against no intervention, while the program was also designed for delivery through routine cancer services and community fitness centers.
The authors concluded that STAMINA provides clinicians with a basis for identifying, referring, and prescribing supervised exercise and dietary advice for men receiving ADT, with the intervention meeting best-practice recommendations and demonstrating cost-effectiveness compared with Optimised Usual Care. The study was funded by the National Institute for Health Research.
The full article is available in The Lancet Oncology.
