A structured way of life intervention incorporating supervised train, dietary recommendation, and behavioral assist helped mitigate deterioration in prostate cancer-specific high quality of life and worsening fatigue amongst males receiving androgen deprivation remedy (ADT) for prostate most cancers, in line with outcomes from the STAMINA randomized trial.
The examine, titled “An integrated lifestyle intervention for mitigation of adverse effects associated with androgen deprivation therapy for prostate cancer (STAMINA): a multicentre, randomised trial,” was printed on-line 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 stays an vital element of therapy for a lot of males with prostate most cancers, however it could actually have substantial adversarial results, together with worsening fatigue and deterioration in cancer-specific high quality of life.
Supervised train is beneficial in nationwide and worldwide prostate most cancers tips, but it’s not often built-in into routine medical care. Against this background, the investigators evaluated STAMINA as a life-style intervention embedded inside prostate most cancers care.
The trial assessed whether or not the STAMINA way of life intervention may enhance cancer-specific high quality of life and fatigue in contrast with behaviorally Optimised Usual Care in males receiving ADT for prostate most cancers.
Study Design
STAMINA was a multicenter, randomized superiority trial performed throughout 15 NHS trusts in England and registered as ISRCTN46385239. Men with prostate most cancers who have been already receiving ADT or have been anticipated to start out ADT inside the following 12 weeks have been eligible. Participants have been randomly assigned in a 5:4 ratio to the STAMINA way of life intervention or Optimised Usual Care.
Randomization was stratified in line with age, length of ADT, receipt of chemotherapy or an androgen receptor pathway inhibitor, and receipt of radiotherapy.
The STAMINA intervention mixed supervised cardio and resistance train with dietary recommendation, behavioral assist, and a complimentary 12-month fitness center membership. Exercise classes have been tailor-made to particular person functionality and initially delivered one-to-one earlier than contributors may transfer to small-group classes.
Supervised train was delivered twice weekly for the primary 13 weeks, adopted by much less frequent supervision negotiated between contributors and medical train specialists over the next 9 months. Optimised Usual Care was itself an energetic intervention. Clinical employees acquired coaching on train suggestions for males receiving ADT, whereas contributors acquired instructional supplies, behavioral prompts, monitoring throughout routine medical visits, and safety-to-exercise checks.
The two main outcomes at 12 months have been prostate cancer-specific high quality of life measured utilizing the Functional Assessment of Cancer Therapy–Prostate (FACT-P) and fatigue measured utilizing the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) subscale. Higher scores on each measures indicated higher outcomes.
Patient Population
Between January 20, 2022, and June 12, 2023, 700 males have been randomly assigned to therapy: 389 to STAMINA and 311 to Optimised Usual Care. The median age was 71.6 years, and 680 sufferers, or 97%, have been White. More than half of contributors had been receiving ADT for 12 weeks or much less. Metastatic illness was documented in 239 sufferers, representing 34% of the examine inhabitants, whereas 136 sufferers, or 19%, have been receiving an androgen receptor pathway inhibitor or chemotherapy, or each.
Adherence to the train program was excessive. At least one supervised train session was delivered to 369 of 389 contributors assigned to STAMINA, equivalent to 95% of the intervention group. The median variety of supervised classes attended was 28. Across 9,580 attended classes, cardio train was carried out in 99% and resistance train in 97%.
STAMINA Mitigates Quality-of-Life Decline During ADT
At 12 months, questionnaires have been returned by 345 of 389 contributors within the STAMINA group and 251 of 311 contributors within the Optimised Usual Care group. STAMINA was superior to Optimised Usual Care for each main outcomes.
For FACT-P, the adjusted imply distinction at 12 months was 4.5 factors in favor of STAMINA (97.232% CI 1.7–7.2; p=0.0004). For FACIT-F, the adjusted imply distinction was 1.9 factors (97.232% CI 0.4–3.4; p=0.0068), additionally favoring STAMINA. Higher FACIT-F scores point out decrease ranges of fatigue. Overall, STAMINA was superior to Optimised Usual Care in offsetting deterioration in prostate cancer-specific high quality of life and fatigue over 12 months.
Several secondary quality-of-life outcomes additionally favored STAMINA. At 12 months, the adjusted imply distinction in FACT-G was 3.7 factors (97.232% CI 1.8–5.7; p<0.0001). The investigators famous that this exceeded the minimal clinically vital distinction threshold of greater than 3 factors.
Physical, social and household, emotional, and useful wellbeing scores additionally favored STAMINA at 12 months. However, there was no statistically important distinction within the prostate cancer-specific FACT-P subscale at the moment level.
General health-related high quality of life, assessed utilizing EQ-5D, was additionally higher with STAMINA all through follow-up. At 12 months, adjusted imply EQ-5D scores have been 0.79 with STAMINA versus 0.76 with Optimised Usual Care (p=0.0001).
Participants within the STAMINA group additionally reported higher leisure-time bodily exercise, with the between-group distinction maintained at 12 months. No proof of a distinction was noticed for concern of most cancers recurrence, whereas bodily outcomes have been related between the teams.
Safety
Thirteen deaths occurred in the course of the trial, together with six within the STAMINA group and 7 within the Optimised Usual Care group. Three severe adversarial occasions have been thought of associated to the STAMINA intervention: transient lack of consciousness, leg ache or weak spot, and again ache. All three contributors recovered. No treatment-related deaths have been reported.
Was STAMINA Cost-Effective?
An financial analysis was performed alongside the medical trial. Using an assumed fitness center membership value of £50 monthly, the incremental cost-effectiveness ratio was £19,077 per quality-adjusted life-year gained. With an assumed month-to-month value of £35, the corresponding estimate was £13,920 per QALY.
Both estimates have been under the £25,000 per QALY threshold utilized by the investigators. Over the 12-month evaluation, STAMINA had a higher than 70% likelihood of being cost-effective underneath the higher-cost state of affairs and a higher than 80% likelihood underneath the lower-cost state of affairs.
Study Limitations
Several limitations ought to be thought of when decoding the findings. The examine inhabitants had restricted ethnic range, with 97% of contributors figuring out as White. The investigators additionally famous a comparatively excessive proportion of contributors who rated themselves as bodily match at baseline. The prostate most cancers therapy panorama additionally developed in the course of the trial. Only round one in 5 contributors was receiving an androgen receptor pathway inhibitor or chemotherapy, though 34% of the general inhabitants had metastatic illness.
Importantly, Optimised Usual Care was not a no-intervention management. It included clinician coaching, instructional supplies, behavioral prompts, and safety-to-exercise assessments and due to this fact represented an enhanced comparator that isn’t usually accessible in routine observe.
Dietary recommendation was included as a part of STAMINA, however adherence to this element was not particularly measured. Missing consequence knowledge have been dealt with utilizing a number of imputation, though sensitivity analyses produced outcomes in line with the first evaluation.
What Do the Findings Mean?
The STAMINA trial confirmed {that a} 12-month way of life intervention integrating supervised cardio and resistance train, dietary recommendation, and behavioral assist into prostate most cancers care can higher mitigate deterioration in prostate cancer-specific high quality of life and worsening fatigue related to ADT than an already enhanced usual-care strategy.
The findings are significantly related as a result of STAMINA was examined towards an energetic comparator somewhat than towards no intervention, whereas this system was additionally designed for supply by way of routine most cancers companies and group health facilities.
The authors concluded that STAMINA supplies clinicians with a foundation for figuring out, referring, and prescribing supervised train and dietary recommendation for males receiving ADT, with the intervention assembly best-practice suggestions and demonstrating cost-effectiveness in contrast with Optimised Usual Care. The examine was funded by the National Institute for Health Research.
The full article is obtainable in The Lancet Oncology.