Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Public ClinicalTrials.gov record NCT02799602. 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
A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.
Study identification
- NCT ID
- NCT02799602
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,306 participants
Conditions and interventions
Conditions
Interventions
- BAY1841788 / darolutamide (ODM-201) Drug
- Standard ADT (androgen deprivation therapy) Drug
- Docetaxel Drug
- Placebo Drug
Drug
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
- Nov 30, 2016 (Actual)
- Primary completion
- Oct 25, 2021 (Actual)
- Completion
- Apr 11, 2023 (Actual)
- Last update posted
- Dec 4, 2025
2016 – 2023
United States locations
- U.S. sites
- 58
- U.S. states
- 28
- U.S. cities
- 55
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Chandler | Arizona | 85224 | — |
| Not listed | Tucson | Arizona | 85724 | — |
| Not listed | Beverly Hills | California | 90211 | — |
| Not listed | Duarte | California | 91010 | — |
| Not listed | Los Angeles | California | 90073 | — |
| Not listed | Palo Alto | California | 94304 | — |
| Not listed | Denver | Colorado | 80211 | — |
| Not listed | Washington D.C. | District of Columbia | 20007 | — |
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Gainesville | Florida | 32610 | — |
| Not listed | Miami Beach | Florida | 33140 | — |
| Not listed | Tampa | Florida | 33612 | — |
| Not listed | Atlanta | Georgia | 30322 | — |
| Not listed | Chicago | Illinois | 60611 | — |
| Not listed | Peoria | Illinois | 61615 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Baltimore | Maryland | 21287 | — |
| Not listed | Towson | Maryland | 21204 | — |
| Not listed | Boston | Massachusetts | 02111 | — |
| Not listed | Boston | Massachusetts | 02114-2696 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | Detroit | Michigan | 48202 | — |
| Not listed | Billings | Montana | 59102 | — |
| Not listed | Omaha | Nebraska | 68130 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Camden | New Jersey | 08103 | — |
| Not listed | Englewood | New Jersey | 07361 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Albuquerque | New Mexico | 87109 | — |
| Not listed | Buffalo | New York | 14203 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Poughkeepsie | New York | 12603 | — |
| Not listed | Rochester | New York | 14642 | — |
| Not listed | The Bronx | New York | 14061 | — |
| Not listed | Concord | North Carolina | 28025 | — |
| Not listed | Winston-Salem | North Carolina | 27157 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Columbus | Ohio | 43210 | — |
| Not listed | Gahanna | Ohio | 43230 | — |
| Not listed | Kettering | Ohio | 45409 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Not listed | Camp Hill | Pennsylvania | 17011 | — |
| Not listed | Pittsburgh | Pennsylvania | 15212 | — |
| Not listed | Charleston | South Carolina | 29401 | — |
| Not listed | Charleston | South Carolina | 29414 | — |
| Not listed | Greenville | South Carolina | 29607 | — |
| Not listed | Myrtle Beach | South Carolina | 29579 | — |
| Not listed | North Charleston | South Carolina | 29406 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Temple | Texas | 76508 | — |
| Not listed | Salt Lake City | Utah | 84112 | — |
| Not listed | Charlottesville | Virginia | 22903 | — |
| Not listed | Falls Church | Virginia | 22042 | — |
| Not listed | Richmond | Virginia | 23284 | — |
| Not listed | Everett | Washington | 98201 | — |
| Not listed | Milwaukee | Wisconsin | 53226 | — |
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 264 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02799602, 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 Dec 4, 2025 · Synced Oct 27, 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 NCT02799602 live on ClinicalTrials.gov.