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Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

ClinicalTrials.gov ID: NCT02200614

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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 5:33 PM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with 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

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 12, 2014 (Actual)
Primary completion
Sep 3, 2018 (Actual)
Completion
Jun 14, 2021 (Actual)
Last update posted
Jun 28, 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 28, 2022 · Synced Oct 20, 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 NCT02200614 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →