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Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
NCT04335682 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Enzalutamide
Study Locations (8)
Illinois
- Northwestern University Feinberg School of Medicine — Chicago
- University of Chicago — Chicago
California
- University of California - San Francisco at Mount Zion — San Francisco
Kansas
- University of Kansas Cancer Center — Fairway
Massachusetts
- Dana Farber Cancer Institute — Boston
Minnesota
- University of Minnesota — Minneapolis
Oklahoma
- University of Oklahoma — Oklahoma City
Wisconsin
- Froedtert and the Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2021-08-17 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04335682
The ClinicalTrials.gov registry entry for NCT04335682 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance Foundation Trials, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which Darolutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04335682 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Illinois, California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04335682 about?
NCT04335682 is a clinical study titled "Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide". 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 ...
What is the current status of trial NCT04335682?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2021-08-17. Estimated completion is 2026-08.
What conditions does trial NCT04335682 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Prostate Cancer, Prostate Cancer Metastatic, Hormone Sensitive Prostate Cancer, Castrate Resistant Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04335682?
The interventions under investigation include: Darolutamide (DRUG), Enzalutamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04335682?
This trial is sponsored by Alliance Foundation Trials, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04335682 being conducted?
This trial has 8 study locations across California, Illinois, Kansas, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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