NCT06660862

Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide	How darolutamide and hormone therapy affects the step count of older men who have prostate cancer
DRUG	Physician choice Androgen Deprivation (Hormone) Therapy	How step count/physical activity affects certain quality of life changes these men experience such as differences in pain, mood, function, memory and fatigue

Timeline

• Start date: 2026-11-01
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2024-10-28
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study