A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Public ClinicalTrials.gov record NCT00554229. 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 Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases. * This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo. * ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases. * All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy. * Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour. * No patients will be deprived of standard prostate cancer therapy.
Study identification
- NCT ID
- NCT00554229
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 896 participants
Conditions and interventions
Conditions
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 2007 (Type not available)
- Primary completion
- Jul 2010 (Actual)
- Completion
- Aug 2011 (Actual)
- Last update posted
- Feb 8, 2016
2007 – 2011
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Tucson | Arizona | — | — |
| Research Site | Greenbrae | California | — | — |
| Research Site | Los Angeles | California | — | — |
| Research Site | Palm Springs | California | — | — |
| Research Site | San Mateo | California | — | — |
| Research Site | Norwich | Connecticut | — | — |
| Research Site | Washington D.C. | District of Columbia | — | — |
| Research Site | Gainsville | Florida | — | — |
| Research Site | Port St.Lucie | Florida | — | — |
| Research Site | Des Moines | Iowa | — | — |
| Research Site | Canton | Ohio | — | — |
| Research Site | Pittsburgh | Pennsylvania | — | — |
| Research Site | Nashville | Tennessee | — | — |
| Research Site | Salt Lake City | Utah | — | — |
| Research Site | Burlington | Vermont | — | — |
| Research Site | Norfolk | Virginia | — | — |
| Research Site | Seattle | Washington | — | — |
| Research Site | Wheeling | West Virginia | — | — |
| Research Site | Milwaukee | Wisconsin | — | — |
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 178 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00554229, 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 Feb 8, 2016 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00554229 live on ClinicalTrials.gov.