Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer.

ClinicalTrials.gov ID: NCT01193257

Public ClinicalTrials.gov record NCT01193257. 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 Sep 5, 2026, 3:32 AM 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 Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.

Brief summary

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

This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy

Study identification

NCT ID
NCT01193257
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
1,099 participants

Conditions and interventions

Interventions

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 14, 2010
Primary completion
May 15, 2013
Completion
Feb 28, 2016
Last update posted
Dec 18, 2018

2010 – 2016

United States locations

U.S. sites
37
U.S. states
22
U.S. cities
36
Facility City State ZIP Site status
Not listed Anchorage Alaska 99508
Not listed Fort Smith Arkansas 72903
Not listed Fountain Valley California 92708
Not listed Los Angeles California 90025
Not listed Riverside California 92501
Not listed San Diego California 92120
Not listed Fort Myers Florida 33916
Not listed Port Saint Lucie Florida 34952
Not listed Indianapolis Indiana 46219
Not listed Jeffersonville Indiana 47130
Not listed New Orleans Louisiana 70112
Not listed Westminster Maryland 21157
Not listed Detroit Michigan 48201
Not listed Jefferson City Missouri 65109
Not listed Las Vegas Nevada 89169
Not listed Hackensack New Jersey 07601
Not listed Albany New York 12208
Not listed East Syracuse New York 13057
Not listed Rochester New York 14623
Not listed Raleigh North Carolina 27607
Not listed Cincinnati Ohio 45230
Not listed Tualatin Oregon 97062
Not listed Lancaster Pennsylvania 17604
Not listed Pittsburgh Pennsylvania 15212
Not listed Greenville South Carolina 29605
Not listed Chattanooga Tennessee 37404
Not listed Nashville Tennessee 37203
Not listed Amarillo Texas 79106
Not listed Bedford Texas 76022
Not listed Dallas Texas 75231
Not listed Dallas Texas 75246
Not listed Odessa Texas 79761
Not listed Tyler Texas 75702
Not listed Webster Texas 77598
Not listed Salt Lake City Utah
Not listed Newport News Virginia 23606
Not listed Kennewick Washington 99336

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 41 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01193257, 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 18, 2018 · Synced Sep 5, 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 NCT01193257 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →