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

NCT06660862 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB24-0691
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Metastatic; Deprivation Therapy

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (11)

• Step count and the Global Health Score

  12 months

• Physical Function

  3, 6, 9, and 12 months.

• Fatigue subscale

  3, 6, 9, and 12 months.

• Pain Severity

  3, 6, 9, and 12 months.

• Occurrence of serious adverse events

  12 months

Study Arms (1)

Darolutamide and physical activity correlation

EXPERIMENTAL

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

Drug: Darolutamide; Drug: Physician choice Androgen Deprivation (Hormone) Therapy

Interventions

Darolutamide DRUG

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

Darolutamide and physical activity correlation

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

Darolutamide and physical activity correlation

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.)
• 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.
• a) 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 \[transfusion of PRBC or PLT for eligibility purposes only will not be allowed\]

You may not qualify if:

• Patients who have previously received any ADT or ARSI within 12 months of metastatic diagnosis are not eligible.
• a) 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.
• a. 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.
• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

o University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

darolutamide; Hormones; Therapeutics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Russell Szmulewitz

  University of Chicago Medicine Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

1-855-702-8222; cancerclinicaltrials@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: October 28, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-09

Locations

US (1)