LIBERTAS: A degendered and transgender-inclusive phase 3 study of apalutamide (APA) plus intermittent vs continuous androgen deprivation therapy (ADT) in participants (pts) with metastatic hormone-sensitive prostate cancer (mHSPC).

TPS5119 Background: Individuals with mHSPC may experience adverse events and decreased quality of life associated with ADT. LIBERTAS, the first degendered and transgender-inclusive PC study, explores the use of APA + intermittent ADT as an ADT-minimizing approach in pts who achieve prostate-specific antigen (PSA) 10 ng/mL (or return to baseline when PSA <10 ng/mL before ADT), or PSA doubling time <6 mo. Outcomes of pts undergoing medical or surgical GAC are evaluated descriptively as a separate cohort. Primary end points: radiographic progression-free survival and hot flash frequency and severity score at 18 mo from randomization. Secondary end points include findings from electronic patient-reported outcomes completed on a mobile device, digital health assessments measuring physical activity and sleep (measured from a wrist-worn device), and neurocognitive function measured using touchscreen-based interactive assays. An independent data monitoring committee will review safety data. ~333 pts will be enrolled over 2 yrs at 86 sites in 9 countries. Clinical trial information: NCT05884398 .