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NCT04335682 · ClinicalTrials.gov registry record · Phase 2
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
A Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by Alliance Foundation Trials.
- Active
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
- 8
- Study locations
NCT04335682 is a Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer that is active but no longer recruiting, run by Alliance Foundation Trials. The registered enrollment target is 111 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 7 states.
The verdict
NCT04335682, a Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, is active but no longer recruiting, sponsored by Alliance Foundation Trials.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Alliance Foundation Trials, which has 20 total studies on file at ClinicalTrials.gov.
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.
NCT04335682 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Illinois, California, Kansas.
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, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer.
What interventions are being tested in trial NCT04335682?
The interventions under investigation include: Darolutamide (DRUG), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT04335682?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
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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