Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Public ClinicalTrials.gov record NCT02200614. 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 Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer
Study identification
- NCT ID
- NCT02200614
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bayer
- Industry
- Enrollment
- 1,509 participants
Conditions and interventions
Interventions
- Darolutamide (Nubeqa, BAY1841788) 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
- Sep 11, 2014
- Primary completion
- Sep 2, 2018
- Completion
- Jun 13, 2021
- Last update posted
- Jun 27, 2022
2014 – 2021
United States locations
- U.S. sites
- 55
- U.S. states
- 28
- U.S. cities
- 51
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Homewood | Alabama | 35209 | — |
| Not listed | Anchorage | Alaska | 99503 | — |
| Not listed | Tucson | Arizona | 85704 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | La Jolla | California | 92093 | — |
| Not listed | Laguna Hills | California | 92653 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Los Angeles | California | 90073-1003 | — |
| Not listed | San Diego | California | 92120 | — |
| Not listed | Whittier | California | 90603 | — |
| Not listed | Denver | Colorado | 80211 | — |
| Not listed | Denver | Colorado | 80220 | — |
| Not listed | Parker | Colorado | 80134 | — |
| Not listed | Boca Raton | Florida | 33486 | — |
| Not listed | Orlando | Florida | 32803 | — |
| Not listed | Port Saint Lucie | Florida | 34952 | — |
| Not listed | Coeur d'Alene | Idaho | 83814 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Evanston | Illinois | 60201-1613 | — |
| Not listed | Springfield | Illinois | 62702 | — |
| Not listed | Greenwood | Indiana | 46143 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Jeffersonville | Indiana | 47130 | — |
| Not listed | West Des Moines | Iowa | 50266 | — |
| Not listed | Wichita | Kansas | 67226 | — |
| Not listed | New Orleans | Louisiana | 70121 | — |
| Not listed | Annapolis | Maryland | 21401 | — |
| Not listed | Baltimore | Maryland | 21204 | — |
| Not listed | Salisbury | Maryland | 21801 | — |
| Not listed | Boston | Massachusetts | 02114 | — |
| Not listed | Grand Rapids | Michigan | 49546 | — |
| Not listed | Royal Oak | Michigan | 48073 | — |
| Not listed | Omaha | Nebraska | 68114 | — |
| Not listed | Omaha | Nebraska | 68130 | — |
| Not listed | Lebanon | New Hampshire | 03756-1000 | — |
| Not listed | Voorhees Township | New Jersey | 08043 | — |
| Not listed | Syracuse | New York | 13210 | — |
| Not listed | The Bronx | New York | 10461 | — |
| Not listed | The Bronx | New York | 10469 | — |
| Not listed | Asheboro | North Carolina | 27203 | — |
| Not listed | Charlotte | North Carolina | 28277 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Cincinnati | Ohio | 45212 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Gahanna | Ohio | 43230 | — |
| Not listed | Middleburg Heights | Ohio | 44130 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Bala-Cynwyd | Pennsylvania | 19004 | — |
| Not listed | Myrtle Beach | South Carolina | 29572 | — |
| Not listed | Nashville | Tennessee | 37209 | — |
| Not listed | Dallas | Texas | 75231 | — |
| Not listed | Fairfax | Virginia | 22031 | — |
| Not listed | Richmond | Virginia | 23235 | — |
| Not listed | Virginia Beach | Virginia | 23462 | — |
| Not listed | Wheeling | West Virginia | 26003 | — |
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 349 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02200614, 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 Jun 27, 2022 · Synced May 6, 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 protocol, eligibility criteria, and contact information for NCT02200614 live on ClinicalTrials.gov.