Multicenter randomized trial of an integrated lifestyle intervention for adverse effects of androgen deprivation therapy in prostate cancer

Androgen deprivation therapy (ADT) for prostate cancer causes substantial adverse effects. The randomized STAMINA trial, at 15 centers in the UK, evaluated the STAMINA lifestyle intervention (supervised aerobic and resistance exercise for 12 months, dietary advice, behavioral support, and complimentary gym membership) for mitigation of these adverse effects. Men on ADT for prostate cancer were randomized (5:4) to STAMINA (n=389) or Optimized Usual Care (OUC; clinician training, educational materials, behavioral prompts, and safety-to-exercise checks; n=311). Primary outcomes were the FACT-P and FACIT-F at 12 months. Primary outcome data were aivalable for 345 patients (89%) in the STAMINA group and 251 patients (81%) in the OUC group. Median age was 71.6 years (IQR 66.3-76.0). STAMINA was superior to OUC in terms of FACT-P score (adjusted mean difference 4.5; p=0.0004) and FACIT-F score (1.9; p=0.0068). Three intervention-related serious adverse events occurred in the STAMINA group (transient loss of consciousness, leg pain or weakness, and back pain); all participants recovered. The authors conclude that the STAMINA lifestyle intervention is effective for mitigating adverse effects of ADT in prostate cancer patients.