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

NCT06660862 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Russell Szmulewitz · University of Chicago Medicine Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2029-11-30
Completion
2029-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660862 on ClinicalTrials.gov