Study on Darolutamide and Hormone Therapy for Patients with Metastatic Hormone-Sensitive Prostate Cancer

Sponsor: University of Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06660862

Provider View

This clinical trial is exploring how the drug darolutamide, combined with standard hormone therapy, affects physical activity and safety in adults with metastatic hormone-sensitive prostate cancer who are considered vulnerable based on a geriatric assessment.

Patient Parameters

Program Overview

The purpose of this study is to see how well the drug darolutamide works when used with standard hormone therapy in patients with metastatic hormone-sensitive prostate cancer. Researchers are particularly interested in how this combination affects physical activity, like step count, and its safety in older adults who are considered vulnerable based on a brief geriatric assessment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a performance status score of 3 or less, indicating varying levels of activity.
  • Must show signs of frailty by meeting one of the following:
    • Score of 3 or 4 on the Katz Activities of Daily Living assessment.
    • Score of 2 or 3 on the Instrumental Activities of Daily Living assessment.
    • Grade 3 event on the Cumulative Illness Score Rating-Geriatrics questionnaire (excluding prostate cancer).
    • Body mass index (BMI) of 21 or less and/or more than 10% weight loss in the last 6 months.
  • Must have confirmed prostate cancer without certain cell features.
  • Must have at least one metastatic bone or soft tissue/visceral lesion documented by specific scans.
  • Must have adequate organ function, including:
    • Sufficient blood cell counts and liver function.
    • Testosterone level of 100 mg/dL or higher.
    • Albumin level of 2.5 g/dL or higher.
  • Must be either untreated or minimally treated for metastatic prostate cancer.
  • Must agree to participate in the IRONMAN registry study.
  • If sexually active, must agree to use two forms of birth control, including a condom, during and after the study.

Exclusion Criteria

  • Cannot have received certain hormone therapies within 12 months of metastatic diagnosis.
  • Cannot have uncontrolled illnesses like infections, heart failure, or psychiatric conditions that would interfere with the study.
  • Cannot have severe kidney issues or be on dialysis.
  • Cannot have small-cell prostate cancer or brain metastases.
  • Cannot have limb defects that prevent wearing an activity tracker.
  • Cannot have had certain cancer treatments, including chemotherapy or immunotherapy, before the study.
  • Cannot be participating in another treatment trial.
  • Cannot have allergies to study drugs or similar medications.
  • Cannot have other active cancers that require treatment.
  • Cannot have significant heart disease or recent heart issues.
  • Cannot have conditions that prevent completing study imaging procedures.

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