Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT04335682

Public ClinicalTrials.gov record NCT04335682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04335682
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
111 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 16, 2021
Primary completion
Aug 31, 2025
Completion
Apr 30, 2026
Last update posted
Jun 17, 2026

2021 – 2026

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
University of California - San Francisco at Mount Zion San Francisco California 94115
Northwestern University Feinberg School of Medicine Chicago Illinois 60611
University of Chicago Chicago Illinois 60637
University of Kansas Cancer Center Fairway Kansas 66205
Dana Farber Cancer Institute Boston Massachusetts 02115
University of Minnesota Minneapolis Minnesota 55455
University of Oklahoma Oklahoma City Oklahoma 73104
Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04335682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2026 · Synced Sep 6, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04335682 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →