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Darolutamide and Hormone Therapy for Metastatic Prostate Cancer

This study is looking at how a drug called darolutamide, when given with standard hormone therapy (Androgen Deprivation Therapy or ADT), affects physical activity in men with metastatic hormone-sensitive prostate cancer. Specifically, researchers want to see if this combination impacts your step count over 6 months. You might be able to join if you are an adult man (18 or older) with this type of prostate cancer and meet certain criteria for frailty, which means you might need some help with daily activities. The study aims to enroll 80 participants to understand how these treatments affect your physical activity and overall safety.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 80 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, step count, is measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06660862

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

Not Yet Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Chicago
~80 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:DarolutamidePhysician choice Androgen Deprivation (Hormone) Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigating the impact of darolutamide in combination with ADT on step count
Measured over 6 months

Conditions

Prostate Cancer

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Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Russell Szmulewitz · PRINCIPAL_INVESTIGATOR · University of Chicago Medicine Comprehensive Cancer Center

Who to contact

Clinical Trials Intake
[email protected]
1-855-702-8222
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
Patients must have at least one metastatic bone and/or soft tissue/visceral lesion documented in the following manners within 42 days prior randomization:
Patients must have adequate organ function:
Testosterone ≥100 mg/dL
Albumin ≥2.5 g/dL
Patients eligible for this study must be either:
Patients must consent and concurrently accrue to the IRONMAN registry study (NCT03151629)
If patient is a sexually active male and/or his female partner is of childbearing potential, patient must agree to use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) from screening through 3 months after the last dose of study drugs.
Concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy or investigational therapy
Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation or other PSMA-targeted radioligand therapy is not allowed
Ongoing participation in any other treatment clinical trial. Concurrent accrual to non-treatment trials such as biomarker or registry trials is allowed.
Use of other investigational drugs within 30 days prior to day of randomization
Known hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes
Diagnosed with other malignancies that require active treatment or may interfere with disease assessment.
Active clinically significant cardiac disease defined as any of the following:
Inability to complete the study imaging procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

Exclusion

Patients who have previously received any ADT or ARSI within 12 months of metastatic diagnosis are not eligible.
Uncontrolled intercurrent illness includes ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, bed-bound status, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participants with known small-cell carcinoma of the prostate or known brain metastasis.
Participants with limb defects precluding accelerometer wear.

What this trial measures

  • Investigating the impact of darolutamide in combination with ADT on step count6 months

    To investigate the impact darolutamide in combination with ADT on the physical activity (digitally collected step count) of vulnerable adults with metastatic hormone-sensitive prostate cancer over a 6-month treatment period.