OncRef

Clinical Trial: NCT04335682

Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Alliance Foundation Trials, LLC.
Information Provided By:Alliance Foundation Trials, LLC.
Last Update Posted:2026-09-21

Study Overview

Brief Summary

This is a prospective, randomized, open-label phase II study comparing cognitive outcomes between men with metastatic and non-metastatic castration resistant prostate cancer (CRPC) or metastatic hormone sensitive prostate cancer (HSPC). Approximately 132 patients will be enrolled. Eligible patients will be randomized in a 1:1 fashion to treatment with enzalutamide 160 mg orally daily or darolutamide 600 mg orally twice daily, in combination with standard LHRH agonist based treatment. Cognitive assessments will be performed using modules from Cambridge Neuropsychological Test Automated Battery (CANTAB) an internationally recognized software for assessing cognitive function and impairment.

Official Title

A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated With Darolutamide or Enzalutamide (ARACOG)

Conditions

Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer

Intervention / Treatment

  • Drug: Darolutamide
  • Drug: Enzalutamide

Other Study ID Numbers

  • AFT-47

Start Date (Actual)

2021-08-17

Primary Completion Date (Actual)

2025-09-01

Study Completion Date (Actual)

2026-05-01

Enrollment (Actual)

111

Study Type

Interventional

Phase

Phase 2