Physical Function During ARSI Treatment

This single arm observational pilot study aims to determine the longitudinal effects of androgen receptor signaling inhibitors (ARSI) in men with advanced prostate cancer. The primary outcome for this trial is physical function, which will be evaluated at baseline, 12 and 24 weeks. Secondary outcomes including body composition, muscle function, balance, arterial stiffness and patient reported outcomes.

Inclusion Criteria:Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.Age ≥ 18 years at the time of consent.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.Diagnosis of metastatic disease from prostate cancer, or recurrent disease following definitive local therapy of prostate cancer, as assessed by their clinicianInitiation of an ARSI (e.g., abiraterone, enzalutamide, apalutamide, or darolutamide) for mPC with concurrent androgen deprivation therapy (ADT).Availability to begin baseline testing within 8 weeks of ARSI treatment initiation.Physician clearance to perform physical assessments.Ability to speak and read English.Exclusion Criteria:Prior ARSI treatmentCurrent chemotherapyHistory of bone fractures or musculoskeletal injuriesNeurological conditions that affect balance and/or muscle strengthIntention to leave the region prior to completion of studyDementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent