This study assesses physical function following androgen receptor signaling inhibitor treatment for patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Androgen deprivation therapy and androgen receptor signaling inhibitor treatments effectively slow tumor growth by suppressing testosterone production, but have adverse effects including reduced physical function and muscular strength, decreased lean mass and bone mineral density, increased body fat and overall decreased quality of life. Information gathered from this study may help researchers understand any changes to physical function after receiving androgen receptor signaling inhibitor treatment for metastatic prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05612880.
PRIMARY OBJECTIVE:
I. To measure physical function (PF) (Short Physical Performance Battery [SPPB], Timed Up and Go [TUG], 400 meter [m] walk) at baseline, 12, and 24 weeks in men with metastatic prostate cancer [mPC] undergoing androgen-receptor signaling inhibitor [ARSI] treatment.
SECONDARY OBJECTIVES:
I. To measure dual energy X-ray absorptiometry [DEXA]-assessed body composition (whole-body and regional percent body fat, bone mineral content, lean mass), computed tomography [CT]-scan cross sectional body composition (skeletal muscle, subcutaneous adipose tissue, and visceral adipose tissue area), and ultrasound muscle thickness and quality at baseline, 12, and 24 weeks in men with mPC undergoing ARSI treatment.
II. To measure grip strength (handgrip dynamometry) at baseline, 12, and 24 weeks in men with mPC undergoing ARSI treatment.
III. To measure muscle power (sit to stand power test) at baseline, 12, and 24 weeks in men with mPC undergoing ARSI treatment.
IV. To measure patient reported outcomes (PROs) of quality of life (QoL), fatigue, anxiety, and depression at baseline, 12, and 24 weeks in men with mPC undergoing ARSI treatment.
EXPLORATORY OBJECTIVE:
I. To investigate the possible association of the measures noted in the primary and secondary objectives by type of ARSI (abiraterone versus [vs]. enzalutamide), stage of mPC (metastatic castration-resistant prostate cancer [mCRPC] vs. metastatic castration-sensitive prostate cancer [mCSPC]) and physical activity levels.
OUTLINE: This is an observational study.
Patients wear an ActiGraph device to track physical activity, complete the handgrip dynamometry test, sit to stand power test, Short Physical Performance Battery tests, Timed Up and Go test, and the 400 meter walk while on study. Patients also undergo DEXA and ultrasound scans and complete surveys and have their medical records reviewed on study.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorErik Hanson
