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Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
NCT04136353 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, 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 1,100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Sydney, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT04136353 reports 20 study locations spanning 8 distinct geographic areas — top geographies include New York, New Jersey, Massachusetts. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04136353?
This trial is sponsored by University of Sydney, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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