Clinical trialNCT04335682CompletedPhase 2Interventional

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

SponsorAlliance Foundation Trials, LLC.Enrollment111Castrate Resistant Prostate CancerHormone Sensitive Prostate CancerMetastatic Prostate CancerNon-metastatic Prostate CancerProstate CancerProstate Cancer Metastatic

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Evanthia Galanis, MD
Alliance Foundation Trials
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California - San Francisco at Mount Zion
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Kansas Cancer Center
Fairway, Kansas, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Darolutamide →Enzalutamide →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Aug 2021
Primary completion: 1 Sept 2025
Completion: 1 May 2026
Last update posted: 18 Jun 2026
Registered enrollment: 111
Registry id: NCT04335682

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.