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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT06660862
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2026
Status verified
Sep 2025
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Darolutamide and physical activity correlation
    To understand how darolutamide plus hormone therapy affects physical activity, we would like to specifically monitor the step count of men receiving these medications.

Primary Outcome Measure

Investigating the impact of darolutamide in combination with ADT on step count [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
o University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637
Clinical Trials Intake
[email protected]
1-855-702-8222
Russell Szmulewitz (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
o University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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