Study on How Androgen Receptor Therapy Affects Thinking Skills in Patients Using Darolutamide or Enzalutamide

Sponsor: Alliance Foundation Trials, LLC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04335682

Provider View

This clinical trial is exploring how two different medications, darolutamide and enzalutamide, affect thinking skills in men with advanced prostate cancer. The study will involve 132 participants who will be randomly assigned to take one of the medications along with standard treatment. Researchers will use special tests to measure changes in cognitive function over time.

Patient Parameters

Program Overview

The purpose of this study is to compare the effects of two medications, darolutamide and enzalutamide, on cognitive function in men with advanced prostate cancer. The study will include 132 participants who will be randomly assigned to receive either darolutamide or enzalutamide, along with standard hormone therapy. Cognitive function will be assessed using a series of tests from the Cambridge Neuropsychological Test Automated Battery (CANTAB), which measures various aspects of thinking and memory. The study will last for 48 weeks, with cognitive assessments conducted at different points to track changes over time.

Description

This study aims to understand how two medications, darolutamide and enzalutamide, affect cognitive function and quality of life in men with advanced prostate cancer. Participants will be randomly assigned to take either darolutamide (600 mg twice daily) or enzalutamide (160 mg daily), in combination with standard hormone therapy. The study will last for 48 weeks, during which cognitive function will be assessed using the CANTAB test, which evaluates different areas of thinking and memory.

The main goal is to see how much cognitive function changes by 24 weeks in each group. Participants will be grouped by age, and they may switch to the other medication at 12 or 24 weeks if certain criteria are met. Blood samples will be collected for additional genetic analysis, and some participants may choose to join an MRI sub-study to further explore brain changes.

The study will help determine if there are differences in cognitive outcomes between the two medications, providing valuable information for managing prostate cancer treatment.

Eligibility Criteria

Key inclusion criteria include:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Progressive disease per PCWG3 criteria with EITHER: Metastatic CRPC or non- metastatic CRPC (M0CRPC)

    • For mCRPC: metastatic disease documented by standard or novel imaging techniques
    • OR for M0CPRC: no evidence of metastatic disease on standard imaging.

  • OR mHSPC

  • Surgically or medically castrated, with testosterone levels of <50 ng/dL. If the patient is medically castrated, continuous dosing with GnRH agonist or antagonist must have been initiated at least 4 weeks prior to randomization and must be continued throughout the study.

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2

  • Able to complete cognitive testing and patient reported outcome surveys in English.

  • Ability to swallow study medications whole.

  • Able to provide informed consent.

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