Randomized PROSTATE-IQ trial to reduce ADT treatment burden for patients with biochemical recurrence after prostatectomy.

TPS5130 Background: Men with PSA recurrence of prostate cancer after prostatectomy often receive Androgen Deprviation Therapy (ADT) with salvage radiation therapy to the prostate resection bed. Traditional ADT improves cancer control; however, it also causes fatigue, sexual dysfunction, hot flashes, cognitive changes, metabolic dysregulation, body composition changes, and negatively impacts men’s quality of life. Methods: The PROSTATE-IQ trial is a randomized multi-center clinical trial that is investigating ways to reduce the adverse effects of ADT treatment. First, the trial uses intrinsic cancer properties assessed by ArteraAI and clinical-pathologic variables to personalize the intensity of Androgen Axis Therapy (AAT). Those with low ArteraAI score are assigned to the Artera Low Cohort and those with either high ArteraAI score, PSA >0.5 ng/ml or nodal involvement are assigned to the Higher-risk Cohort. Second, the trial randomizes men between traditional ADT and apalutamide-based therapy. We hypothesize that the apalutamide-based therapy will reduce the adverse effects of treatment and thereby improve quality of life. 220 men in the Artera Low Cohort are being randomized between 6 months of ADT vs. 6 months of apalutamide monotherapy. 220 men in the Higher-risk Cohort are being randomized between 24 months of ADT (winning arm of RADICALS-HD trial) vs. 6 months of apalutamide and ADT (winning arm of FORMULA 509 trial). We hypothesize that the apalutamide-based treatments will reduce fatigue and boost activity, sleep, and cognitive function. Patients wear an activity and sleep tracker, undergo cognitive assessments, and complete validated fatigue, leisure activity, and mental health questionnaires. We will compare fatigue, activity, sleep, mental health, body composition, metabolic dysregulation, quality of life, and cancer control between treatment arms. This trial will be impactful because it is the first to use the validated ArteraAI test to personalize intensity of androgen axis therapy and because it will reduce the adverse effects of treatment and improve quality of life for prostate cancer survivors treated with salvage radiation and androgen axis therapy.