3246 - Randomized PROSTATE-IQ Trial to Reduce ADT Treatment Burden for Patients with Biochemical Recurrence after Prostatectomy
Presenter(s)
K. E. Hoffman1, P. L. Nguyen2, A. Zurita-Saavedra3, A. Morgans4, D. Rathkopf5, X. Shen6, E. Wulff-Burchfield7, and M. A. Kollmeier8; 1Division of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 2Department of Radiation Oncology, Brigham and Women’s Hospital/Dana-Farber Cancer Institute, Boston, MA, 3Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 4Dana Farber Cancer Institute, Boston, MA, 5Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, 6Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, KS, 7University of Kansas Medical Center, Kansas City, KS, 8Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY
Purpose/Objective(s):
Men with PSA recurrence of prostate cancer after prostatectomy often receive Androgen Deprivation 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.Materials/Methods:
The PROSTATE-IQ trial (NCT 06274047) is a randomized multi-center clinical trial that is investigating ways to optimize duration and intensity of hormonal therapy during salvage radiation to reduce the adverse effects of treatment. The trial integrates 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 =1 of the following features is in the Higher-risk Cohort: high ArteraAI score, PSA >0.5 ng/ml or nodal involvement. The trial then randomizes men within each cohort to different durations and intensities of AAT. We hypothesize that the groups receiving apalutamide-based therapy will have a lower adverse effect burden and superior quality of life vs the alternate treatment group in their risk cohort. 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 (similar to winning arm of FORMULA 509 trial). We hypothesize that the apalutamide-based treatments will have lower rates of fatigue and higher rates of 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.Results:
TBDConclusion:
This trial will be impactful because it is the first to integrate the validated ArteraAI test to personalize intensity of AAT and because it will reduce adverse effects and improve quality of life by optimizing the duration and intensity of systemic therapy for prostate cancer survivors treated with salvage radiation.