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
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
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.
Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this study.
Exclusion Criteria:
Patients who answer TRUE to the following may NOT be eligible to participate in this study.
Mystle Beach, South Carolina, United States
Raleigh, South Carolina, United States
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
(Wilrijk) Antwerpen, Belgium
North York, Ontario, Canada
Greenfeild Park, Quebec, Canada
Point-Claire, Quebec, Canada
Jiangsu, China
Gelsenkirchen-Buer, Germany
Kirchheim/Teck, Germany
Muehlheim An Der Ruhr, Germany
Muenchen-Planegg, Germany
Waltshut-Tiengen, Germany
Kolkota, West Bengal, India
Jeruslaem, Israel
Tel-HaShomer - Ramat Gan, Israel
Ibaraki-machi, Ibaraki, Japan
Kita-gun, Kagawa-ken, Japan
Sunto-gun, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Fuchu_city, Tokyo, Japan
Itabashi-Ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-Ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Distrito Federal, Mexico City, Mexico
Tygerberg, Cape Town, South Africa
Seo-gu, Busan, South Korea
Gangnam-gu, Seoul, South Korea
Seodaemun-gu, Seoul, South Korea
Seongbuk-gu, Seoul, South Korea
Songpa-gu, Seoul, South Korea
A Corunna, Spain
Ch-4031 Basel, Switzerland