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Prostate CancerPhase 4NCT06660862

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

A Phase 4 study testing Darolutamide and Physician choice Androgen Deprivation (Hormone) Therapy in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Darolutamide and Physician choice Androgen Deprivation (Hormone) Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
Nov 2026to Nov 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Katz Activities of Daily Living (ADL) Assessment Score 3 or 4 out of 533.
  • 4-Instrumental activities of daily living (4-IADL) assessment score 2 or 3 out of 4 34.
  • A Grade 3 event on the Cumulative Illness Score Rating-Geriatrics (CISR-G) questionnaire35 (excluding prostate cancer.)
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  • Body mass index (BMI) ≤21 kg/m² and/or >10% weight loss in the last 6 months
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
  • Patients without histologic evidence of prostate cancer are eligible if have documented metastatic disease and PSA>50ng/dL
  • Patients must have at least one metastatic bone and/or soft tissue/visceral lesion documented in the following manners within 42 days prior randomization:
  • Metastatic disease to the bone (in any distribution) visible on 99Tc-MDP bone scintigraphy or PSMA-PET on either pre-ADT scans or baseline scans AND/ OR
  • Lymph node metastases of any size or distribution (PSMA-PET positive or 1.5cm in short access to support metastatic prostate cancer diagnosis).
  • Visceral metastases of any size or distribution. If a participant has a history of visceral metastases at any time prior to randomization, he should be coded as having visceral metastases at baseline (i.e., patients with visceral metastases prior to ADT that disappear at baseline will be counted as having visceral metastases and would therefore have high volume disease for stratification purposes).
  • Patients must have adequate organ function:
  • Bone marrow reserve ANC ≥1.5 x 109/L Platelets ≥100 x 109/L, Hemoglobin ≥8 g/dL [transfusion of PRBC or PLT for eligibility purposes only will not be allowed]
  • Hepatic: Total bilirubin ≤2 x the institutional upper limit of normal (ULN), for patients with known Gilbert's Syndrome ≤3 x ULN is permitted. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases
  • Testosterone ≥100 mg/dL
  • Albumin ≥2.5 g/dL
  • Patients eligible for this study must be either:
  • Completely untreated (treatment-naïve) for metastatic prostate cancer.
  • Minimally treated, which includes:
  • Use of LHRH agonists/antagonists or bilateral orchiectomy, with or without a first-generation antiandrogen (e.g., bicalutamide, flutamide), for up to 45 days prior to joining the study.
  • Any first-generation antiandrogen must be stopped before beginning the study treatment or within 45 days of starting these treatments, whichever is earlier.
  • 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.

Who cannot join

  • Patients who have previously received any ADT or ARSI within 12 months of metastatic diagnosis are not eligible.
  • Patients who received ADT and/or ARSI for locally advanced disease or in an adjuvant or salvage setting are eligible, provided this treatment was not within 12 months before their metastatic diagnosis.
  • 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.
  • Patients with eGFR <15 or on dialysis are excluded
  • Participants with known small-cell carcinoma of the prostate or known brain metastasis.
  • Participants with limb defects precluding accelerometer wear.
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  • Any prior systemic anti-prostate cancer therapy (with the exception of the drugs listed on inclusion criteria), including chemotherapy, Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors, immunotherapy or biological therapy (including monoclonal antibodies).
  • 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:
  • NYHA class 3/4 congestive heart failure within 6 months prior to ICF signature unless treated with improvement and echocardiogram or MUGA demonstrates EF > 45% with improvement in symptoms to class < 3.
  • History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants in the study such as: Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, complete left bundle branch block, high-grade atrioventicular (AV) block (e.g., bifascicular block, Mobitz type II and third degree AV block)
  • Cardiac or cardiac repolarization abnormality, including any of the following: History of myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Intake contact

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

United States1 site

  • o University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Clinical Trials Intake, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

    Russell Szmulewitz

Other trials in United States

About this study

Official title: 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

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
Being tested
Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy
Keywords
Metastatic, Deprivation Therapy
Medical subject headings
Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    How darolutamide and hormone therapy affects the step count of older men who have prostate cancer

  • Physician choice Androgen Deprivation (Hormone) TherapyDrug

    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 groups in NCT06660862
Study groupRoleWhat they receive
Darolutamide and physical activity correlationExperimentalTo understand how darolutamide plus hormone therapy affects physical activity, we would like to specifically monitor the step count of men receiving these medications.
Receives: Drug: Darolutamide; Drug: Physician choice Androgen Deprivation (Hormone) Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigating the impact of darolutamide in combination with ADT on step count

    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.

    Measured: 6 months

Secondary outcomes (11)

  1. Step count and the Global Health Score

    To examine the relationship between step count and the Global Health Score from the EORTC QLQ-C30.

    Measured: 12 months

  2. Physical Function

    To examine the relationship between step count and the Physical Function subscale from the EORTC QLQ-C30.

    Measured: 3, 6, 9, and 12 months.

  3. Fatigue subscale

    To examine the relationship between step count and the Fatigue subscale from the EORTC QLQ-C30.

    Measured: 3, 6, 9, and 12 months.

  4. Pain Severity

    To examine the relationship between step count and Pain Severity from the Brief Pain Inventory (BPI).

    Measured: 3, 6, 9, and 12 months.

  5. Occurrence of serious adverse events

    To relate step count to the occurrence of serious adverse events over 12 months of treatment with darolutamide + ADT.

    Measured: 12 months

  6. Digitally collected step count

    To investigate the impact of darolutamide with ADT on digitally collected step count at 12 months of treatment.

    Measured: 12 months

  7. Geriatric assessment parameters

    To investigate the impact of darolutamide with ADT on geriatric assessment parameters by G-CODE over a 12-month interval.

    Measured: 12 months

  8. Safety of darolutamide with ADT

    To characterize the safety of darolutamide with ADT in vulnerable adults captured through assessment of adverse events by CTCAE v5.0.

    Measured: 12 months

  9. Mobility ability

    To investigate the effect of darolutamide with ADT on mobility, measured by the Timed Up and Go (TUG) test.

    Measured: 3, 6, 9, and 12 months

  10. Grip strength ability

    To investigate the effect of darolutamide with ADT on grip strength, measured using a dynamometer.

    Measured: 3, 6, 9, and 12 months

  11. Lower-body strength ability

    To investigate the effect of darolutamide with ADT on lower-body strength, measured using the Chair Stand Test.

    Measured: 3, 6, 9, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2024
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2029 (estimated)
  4. Study completionNov 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06660862
Sponsor's protocol ID
IRB24-0691
Status last verified
Sep 2025
First submitted
11 Sep 2024
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Darolutamide and Physician choice Androgen Deprivation (Hormone) Therapy in people with Prostate Cancer, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Intake (1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigating the impact of darolutamide in combination with ADT on step count (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06660862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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