Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
Public ClinicalTrials.gov record NCT04136353. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04136353
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,100 participants
Conditions and interventions
Conditions
Interventions
- Darolutamide Drug
- Placebo oral tablet Drug
- Luteinizing Hormone-Releasing Hormone Analog Drug
- External Beam Radiotherapy Radiation
Drug · Radiation
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 31, 2020 (Actual)
- Primary completion
- Jan 31, 2028 (Estimated)
- Completion
- Jul 31, 2028 (Estimated)
- Last update posted
- May 6, 2026
2020 – 2028
United States locations
- U.S. sites
- 19
- U.S. states
- 7
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Dana Farber Cancer Institute - St. Elizabeth's | Brighton | Massachusetts | 02135 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Dana Farber Cancer Institute - Milford | Milford | Massachusetts | 01757 | — |
| XCancer Omaha/Urology Cancer Center | Omaha | Nebraska | 68130 | — |
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| New Jersey Urology Saddle Brook | Clifton | New Jersey | 07013 | — |
| Memorial Sloan Kettering Monmouth | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | — |
| New Jersey Urology Voorhees | Voorhees Township | New Jersey | 08043 | — |
| New Mexico Oncology and Hematology Specialists | Albuquerque | New Mexico | 87109 | — |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | — |
| New York University Langone Long Island | Mineola | New York | 11501 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | — |
| Dayton Physicians Network | Kettering | Ohio | 45409 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04136353, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 6, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04136353 live on ClinicalTrials.gov.