ARAMON Study: How Darolutamide Affects Testosterone Levels in Men with Untreated Prostate Cancer Compared to Enzalutamide

Sponsor: Bayer

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05526248

Provider View

This study is exploring how the drug Darolutamide affects testosterone levels in men with prostate cancer that hasn't been treated with hormone therapy, compared to another drug called Enzalutamide. The goal is to find out if Darolutamide causes fewer side effects.

Patient Parameters

Program Overview

This study is for men with prostate cancer that has returned after initial treatment like surgery or radiation, but hasn't been treated with hormone therapy yet. The cancer is indicated by a rise in PSA levels, a protein linked to prostate cancer. Male hormones like testosterone can help prostate cancer grow, so treatments often aim to reduce these hormones. Darolutamide and Enzalutamide are drugs that block these hormones from helping cancer grow. This study will compare how these drugs affect testosterone levels and side effects. The study has two stages. In the first stage, all participants will take Darolutamide for up to a year, with regular checks on testosterone levels. If results are promising, the second stage will compare Darolutamide and Enzalutamide. Participants will have regular health checks, including blood tests, heart and lung exams, and scans to monitor cancer growth.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older.
  • Diagnosed with prostate cancer confirmed by lab tests.
  • Previously treated with surgery or radiation for prostate cancer.
  • PSA levels indicating cancer return after initial treatment.
  • Less than 5 small, non-painful cancer spots on scans.
  • PSA doubling time of 20 months or less.
  • Good overall health with an ECOG score of 0 or 1.
  • Testosterone levels above 150 ng/dl.
  • Adequate organ function based on recent tests.
  • Not participated in another drug trial in the last 30 days.

Exclusion Criteria

  • Previous hormone therapy for prostate cancer within the last 6 months.
  • Recent radiation or major surgery.
  • Use of certain steroids recently or expected during the study.
  • Recent serious heart issues like heart attack or stroke.
  • Uncontrolled high blood pressure.
  • Digestive issues affecting drug absorption.
  • History of other significant cancers, except certain skin or bladder cancers.
  • Previous use of similar prostate cancer drugs.
  • History of breast tissue growth in men.
  • Use of herbal products affecting prostate cancer or PSA levels recently.

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