University of Chicago
This prospective clinical trial aims to investigate the impact of darolutamide in combination with standard-of-care androgen deprivation on physical activity, specifically step count, and its correlation with important markers of safety in vulnerable adults who screen positive by a brief geriatric assessment (GA) and metastatic hormone-sensitive prostate cancer.
Inclusion Criteria: * Patients must be aged ≥18 years. * Patients must exhibit an ECOG performance status of ≤3. * Patients must screen positive for frailty by having ONE of the following: 1. Katz Activities of Daily Living (ADL) Assessment Score 3 or 4 out of 533. 2. 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3 out of 4 34. 3. A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire35 (excluding prostate cancer.) 4. Body mass index (BMI) ≤21 kg/m² and/or \>10% weight loss in the last 6 months * Patients must have histolog…
How darolutamide and hormone therapy affects the step count of older men who have prostate cancer
How step count/physical activity affects certain quality of life changes these men experience such as differences in pain, mood, function, memory and fatigue
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