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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: Active Phase 2 study of Prostate Cancer and Metastatic Prostate Cancer, sponsored by Alliance Foundation Trials.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To compare the effects of treatment with enzalutamide (ENZ) versus darolutamide (DARO) on the cognitive function of men with non-metastatic and metastatic castration-resistant prostate cancer by comparing the change in the maximally changed cognitive domain utilizing Cambridge Neuropsychological Test Automated Battery \[CANTAB\] cognitive tests from baseline in patients in each study arm.Tests available in the CANTAB battery include tests of learning and executive function; working memory; visua
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 |
What the registry record for NCT04335682 still lists
NCT04335682 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (82% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04335682's enrollment target sits among peer trials
111 319th of 735 higher than 417 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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