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NCT04136353 · ClinicalTrials.gov registry record · Phase 3
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
A Phase 3 study of Prostate Cancer, sponsored by University of Sydney.
- Active
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
- 20
- Study locations
NCT04136353 is a Phase 3 study of Prostate Cancer that is active but no longer recruiting, run by University of Sydney. The registered enrollment target is 1,100 participants, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 8 states.
The verdict
NCT04136353, a Phase 3 study of Prostate Cancer, is active but no longer recruiting, sponsored by University of Sydney.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
Conditions Studied
Interventions
- DRUG Darolutamide
- DRUG Placebo oral tablet
- RADIATION External Beam Radiotherapy
- DRUG Luteinizing Hormone-Releasing Hormone Analog
Study Locations (20)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- New York University Langone Long Island - Mineola
- New York University Langone Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- New Jersey Urology Saddle Brook - Clifton
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
- New Jersey Urology Voorhees - Voorhees Township
Massachusetts
- Dana-Farber Cancer Institute - Boston
- Dana Farber Cancer Institute - St. Elizabeth's - Brighton
- Lahey Hospital and Medical Center - Burlington
- Dana Farber Cancer Institute - Milford - Milford
Nebraska
- XCancer Omaha/Urology Cancer Center - Omaha
New Mexico
- New Mexico Oncology and Hematology Specialists - Albuquerque
Ohio
- Dayton Physicians Network - Kettering
Washington
- Seattle Cancer Care Alliance - Seattle
New South Wales
- Border Medical Oncology Research Unit - Albury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2020-03-31 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04136353
The ClinicalTrials.gov registry entry for NCT04136353 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 607-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% higher). The listed sponsor is University of Sydney, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Darolutamide is the first listed.
NCT04136353 reports 20 study locations spanning 8 distinct geographic areas - top geographies include New York, New Jersey, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04136353 about?
NCT04136353 is a clinical study titled "Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate". The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.
What is the current status of trial NCT04136353?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2020-03-31. Estimated completion is 2028-07-31.
What conditions does trial NCT04136353 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04136353?
The interventions under investigation include: Darolutamide (DRUG), Placebo oral tablet (DRUG), External Beam Radiotherapy (RADIATION), Luteinizing Hormone-Releasing Hormone Analog (DRUG).
Who is sponsoring clinical trial NCT04136353?
This trial is sponsored by University of Sydney, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04136353 being conducted?
This trial has 20 study locations across Massachusetts, Nebraska, New Jersey, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.