Study Stopped
early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
ENTHUSE M0
A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
1 other identifier
interventional
2,577
37 countries
313
Brief Summary
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC). This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments. ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases. All patients participating in this clinical trial will receive existing 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Jan 2008
313 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
June 1, 2012
CompletedSeptember 3, 2012
April 1, 2012
3 years
January 24, 2008
April 26, 2012
August 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Number of participants who have died at early analysis data cut off (DCO)
From date of randomization until date of death, assessed up to 33 months
Progression Free Survival
Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Secondary Outcomes (3)
Health Related Quality of Life
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Prostate-specific Antigen (PSA) Progression
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Time to Symptomatic Progression
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching Placebo
ZD4054
EXPERIMENTALZD4054 (Zibotentan)
Interventions
Eligibility Criteria
You may qualify if:
- Patients who answer TRUE to the following criteria may be eligible to participate in this study.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- Currently receiving treatment with surgical or medical castration
You may not qualify if:
- Patients who answer TRUE to the following may NOT be eligible to participate in this study.
- Currently using opiate based pain killers for cancer related pain
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (322)
Research Site
Tucson, Arizona, United States
Research Site
Greenbrae, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Denver, Colorado, United States
Research Site
Norwich, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Boca Raton, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Ocala, Florida, United States
Research Site
Port Saint Lucie, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Macon, Georgia, United States
Research Site
Kansas City, Kansas, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Rockville, Maryland, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Brooklyn, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Bismarck, North Dakota, United States
Research Site
Canton, Ohio, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Charleston, South Carolina, United States
Research Site
Mystle Beach, South Carolina, United States
Research Site
Raleigh, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
San Antonio, Texas, United States
Research Site
Burlington, Vermont, United States
Research Site
Seattle, Washington, United States
Research Site
Wenatchee, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Santa Fe, Santa Fe Province, Argentina
Research Site
Darlinghurst, New South Wales, Australia
Research Site
Hornsby, New South Wales, Australia
Research Site
Westmead, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Wodonga, Victoria, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Sydney, Australia
Research Site
Graz, Austria
Research Site
Innsbruck, Austria
Research Site
Wels, Austria
Research Site
(Wilrijk) Antwerpen, Belgium
Research Site
Brussels, Belgium
Research Site
Edegem, Belgium
Research Site
Ghent, Belgium
Research Site
Kortrijk, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Research Site
Goiânia, Goiás, Brazil
Research Site
Belo Horizonte, Minas Gerais, Brazil
Research Site
Curitiba, Paraná, Brazil
Research Site
Londrina, Paraná, Brazil
Research Site
Rio de Janeiro, Rio de Janeiro, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
Santo André, São Paulo, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Winnipeg, Manitoba, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Kitchener, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
North York, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Greenfeild Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Point-Claire, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
Research Site
La Serena, Chile
Research Site
Santiago, Chile
Research Site
Temuco, Chile
Research Site
Viña del Mar, Chile
Research Site
Nanjing, Jiangsu, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Beijing, China
Research Site
Chongqing, China
Research Site
Guangzhou, China
Research Site
Hubei, China
Research Site
Jiangsu, China
Research Site
Shanghai, China
Research Site
Shanxi, China
Research Site
Tianjin, China
Research Site
Zejiang, China
Research Site
Bogotá, Colombia
Research Site
Medellín, Colombia
Research Site
Brno, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Jablonec nad Nisou, Czechia
Research Site
Kroměříž, Czechia
Research Site
Olomouc, Czechia
Research Site
Prague, Czechia
Research Site
Ústí nad Labem, Czechia
Research Site
Aalborg, Denmark
Research Site
Copenhagen, Denmark
Research Site
Frederiksberg, Denmark
Research Site
Herlev, Denmark
Research Site
Holstebro, Denmark
Research Site
Odense, Denmark
Research Site
Roskilde, Denmark
Research Site
Helsinki, Finland
Research Site
Joensuu, Finland
Research Site
Oulu, Finland
Research Site
Seinäjoki, Finland
Research Site
Tampere, Finland
Research Site
Caen, France
Research Site
Créteil, France
Research Site
Lille, France
Research Site
Lyon, France
Research Site
Marseille, France
Research Site
Montpellier, France
Research Site
Orléans, France
Research Site
Paris, France
Research Site
Pierre-Bénite, France
Research Site
Poitiers, France
Research Site
Reims, France
Research Site
Rennes, France
Research Site
Rouen, France
Research Site
Suresnes, France
Research Site
Toulouse, France
Research Site
Vandœuvre-lès-Nancy, France
Research Site
Villejuif, France
Research Site
Augsburg, Germany
Research Site
Bad Ems, Germany
Research Site
Berlin, Germany
Research Site
Bonn, Germany
Research Site
Borken, Germany
Research Site
Chemnitz, Germany
Research Site
Emmendingen, Germany
Research Site
Fürth, Germany
Research Site
Gelsenkirchen-Buer, Germany
Research Site
Germering, Germany
Research Site
Göttingen, Germany
Research Site
Holzminden, Germany
Research Site
Kirchheim/Teck, Germany
Research Site
Leipzig, Germany
Research Site
Lübeck, Germany
Research Site
Mannheim, Germany
Research Site
Muehlheim An Der Ruhr, Germany
Research Site
Muenchen-Planegg, Germany
Research Site
Mühlacker, Germany
Research Site
München, Germany
Research Site
Münster, Germany
Research Site
Reutlingen, Germany
Research Site
Rostock, Germany
Research Site
Tübingen, Germany
Research Site
Waltshut-Tiengen, Germany
Research Site
Wuppertal, Germany
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Győr, Hungary
Research Site
Miskolc, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Szeged, Hungary
Research Site
Székesfehérvár, Hungary
Research Site
Ahmedabad, Gujarat, India
Research Site
Nadiād, Gujarat, India
Research Site
Kochi, Kerala, India
Research Site
Pune, Maharashtra, India
Research Site
Chennai, Tamil Nadu, India, India
Research Site
Lucknow, Uttar Pradesh, India
Research Site
Kolkota, West Bengal, India
Research Site
New Delhi, India
Research Site
Dublin, Ireland
Research Site
Beersheba, Israel
Research Site
Be’er Ya‘aqov, Israel
Research Site
Haifa, Israel
Research Site
Holon, Israel
Research Site
Jeruslaem, Israel
Research Site
Petah Tikva, Israel
Research Site
Tel-HaShomer - Ramat Gan, Israel
Research Site
Ancona, Italy
Research Site
Bari, Italy
Research Site
Bergamo, Italy
Research Site
Bologna, Italy
Research Site
Catania, Italy
Research Site
Como, Italy
Research Site
Florence, Italy
Research Site
Genova, Italy
Research Site
Messina, Italy
Research Site
Milan, Italy
Research Site
Pisa, Italy
Research Site
Rome, Italy
Research Site
Terni, Italy
Research Site
Varese, Italy
Research Site
Hirosaki, Aomori, Japan
Research Site
Chiba, Chiba, Japan
Research Site
Narashino, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Ōtake, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Ibaraki-machi, Ibaraki, Japan
Research Site
Mito, Ibaraki, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Kita-gun, Kagawa-ken, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Kamigyō-ku, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Ueda, Nagano, Japan
Research Site
Nagasaki, Nagasaki, Japan
Research Site
Kashihara, Nara, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Kurashiki, Okayama-ken, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Ōsaka-sayama, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Wako, Saitama, Japan
Research Site
Hamamatsu, Shizuoka, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Fuchu_city, Tokyo, Japan
Research Site
Itabashi-Ku, Tokyo, Japan
Research Site
Meguro-ku, Tokyo, Japan
Research Site
Minato-Ku, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku-ku, Tokyo, Japan
Research Site
Liepāja, Latvia
Research Site
Riga, Latvia
Research Site
Distrito Federal, Mexico City, Mexico
Research Site
Mexico City, Mexico City, Mexico
Research Site
's-Hertogenbosch, Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Arnhem, Netherlands
Research Site
Eindhoven, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Tilburg, Netherlands
Research Site
Trondheim, Norway
Research Site
Tønsberg, Norway
Research Site
Arequipa, Peru
Research Site
Bellavista, Peru
Research Site
Jesus Maria, Peru
Research Site
Lima, Peru
Research Site
Gdynia, Poland
Research Site
Kielce, Poland
Research Site
Kościerzyna, Poland
Research Site
Szczecin, Poland
Research Site
Warsaw, Poland
Research Site
Wroclaw, Poland
Research Site
Coimbra, Portugal
Research Site
Porto, Portugal
Research Site
Timișoara, Timiș County, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-Napoca, Romania
Research Site
Omsk, Omsk Oblast, Russia
Research Site
Izhevsk, Russia, Russia
Research Site
Tomsk, Tomsk Oblast, Russia
Research Site
Barnaul, Russia
Research Site
Kursk, Russia
Research Site
Moscow, Russia
Research Site
Saint Petersburg, Russia
Research Site
Sochi, Russia
Research Site
Voronezh, Russia
Research Site
Belgrade, Serbia
Research Site
Niš, Serbia
Research Site
Novi Sad, Serbia
Research Site
Observatory, Cape Town, South Africa
Research Site
Tygerberg, Cape Town, South Africa
Research Site
Overport, Durban, South Africa
Research Site
Parktown, Johannesburg, South Africa
Research Site
Pietermaritzburg, South Africa
Research Site
Pretoria, South Africa
Research Site
Seo-gu, Busan, South Korea
Research Site
Bundang-Gu, Seongnam-si, Gyeonggi-do, South Korea
Research Site
Gangnam-gu, Seoul, South Korea
Research Site
Seodaemun-gu, Seoul, South Korea
Research Site
Seongbuk-gu, Seoul, South Korea
Research Site
Songpa-gu, Seoul, South Korea
Research Site
Elche, Alicante, Spain
Research Site
Barakaldo, Bizkaia, Spain
Research Site
Bilbao, Vizcaya, Spain
Research Site
A Corunna, Spain
Research Site
Barcelona, Spain
Research Site
Madrid, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Gothenburg, Sweden
Research Site
Helsingborg, Sweden
Research Site
Jönköping, Sweden
Research Site
Örebro, Sweden
Research Site
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Aarau, Switzerland
Research Site
Ch-4031 Basel, Switzerland
Research Site
Locarno, Switzerland
Research Site
Zurich, Switzerland
Research Site
Taipei, Taiwan
Research Site
Ankara, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Izmir, Turkey (Türkiye)
Research Site
Reading, Berkshire, United Kingdom
Research Site
Cottingham, East Yorkshire, United Kingdom
Research Site
Stevenage, Hertfordshire, United Kingdom
Research Site
Maidstone, Kent, United Kingdom
Research Site
Guildford, Surrey, United Kingdom
Research Site
Cambridge, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Huddersfield, United Kingdom
Research Site
Liverpool, United Kingdom
Research Site
London, United Kingdom
Research Site
Manchester, United Kingdom
Research Site
Newcastle upon Tyne, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Kurt Miller, Prof., M.D.
Charite University, Berlin, Germany
- PRINCIPAL INVESTIGATOR
Tia Higano, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 29, 2008
Study Start
January 1, 2008
Primary Completion
January 1, 2011
Study Completion
May 1, 2011
Last Updated
September 3, 2012
Results First Posted
June 1, 2012
Record last verified: 2012-04