Prostate Cancer Clinical Trial
— ENTHUSE M1Official 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.
Verified date | April 2012 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 896 |
Est. completion date | August 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in this trial. 1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases) 2. Increasing Prostate Specific Antigen (PSA) over a one month period 3. No pain, or mild pain from prostate cancer 4. Currently receiving treatment with surgical or medical castration Exclusion Criteria: Patients who answer TRUE to the following may NOT eligible to participate in this trial. 1. Currently using opiates based pain killers) 2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone) 3. Suffering from heart failure or had a myocardial infarction within last 6 months 4. A history of epilepsy or seizures |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Research Site | Buenos Aires | Buenos Aires Province |
Argentina | Research Site | Santa Fe | Santa Fe Province |
Australia | Research Site | Ashford | South Australia |
Australia | Research Site | Hornsby | New South Wales |
Australia | Research Site | Redcliffe | Queensland |
Australia | Research Site | St Leonards | New South Wales |
Australia | Research Site | Subiaco | Western Australia |
Austria | Research Site | Graz | |
Austria | Research Site | Wels | |
Belgium | Research Site | Brussels | |
Belgium | Research Site | Gent | |
Belgium | Research Site | Kortrijk | |
Belgium | Research Site | Leuven | |
Brazil | Research Site | Belo Horizonte | Minas Gerais |
Brazil | Research Site | Curitiba | Parana |
Brazil | Research Site | Fortaleza | Ceara |
Brazil | Research Site | Goiania | Goias |
Brazil | Research Site | Porto Alegre | Rio Grande do Sul |
Brazil | Research Site | Ribeirao Preto | Sao Paulo |
Brazil | Research Site | Santo Andre | Sao Paulo |
Brazil | Research Site | Sao Paulo | |
Canada | Research Site | Barrie | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Granby | Quebec |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Kentville | Nova Scotia |
Canada | Research Site | Kitchener | Ontario |
Canada | Research Site | Laval | Quebec |
Canada | Research Site | London | Ontario |
Canada | Research Site | Mississauga | Ontario |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | North York | Ontario |
Canada | Research Site | Oakville | Ontario |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Point-Claire | Quebec |
Canada | Research Site | Quebec | |
Canada | Research Site | Quebec City | Quebec |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
China | Research Site | Haidian District | Beijing |
China | Research Site | Nanjing | Jiangsu |
China | Research Site | Pudong New Area | Shanghai |
China | Research Site | Shanghai | Shanghai |
China | Research Site | Wuhan | Hubei |
China | Research Site | Xi Cheng District | Beijing |
China | Research Site | Xi'an | Shanxi |
China | Research Site | Xicheng District | Beijing |
China | Research Site | Xuhui District | Shanghai |
Czech Republic | Research Site | Brno | |
Czech Republic | Research Site | Olomouc | |
Czech Republic | Research Site | Prague 4 | Prague |
Czech Republic | Research Site | Prague 6 | Prague |
Czech Republic | Research Site | Usti nad Labem | |
Denmark | Research Site | Aalborg | |
Denmark | Research Site | Aarhus | |
Denmark | Research Site | Herlev | |
Denmark | Research Site | Kobenhavn | |
Finland | Research Site | Joensuu | |
Finland | Research Site | Kajaanintie | |
Finland | Research Site | Tampere | |
France | Research Site | Montpellier | |
France | Research Site | Paris | |
France | Research Site | Poitiers Cedex | |
France | Research Site | Suresnes | |
France | Research Site | Toulouse | |
France | Research Site | Villejuif | |
Germany | Research Site | Augsburg | |
Germany | Research Site | Bad Gegeberg | |
Germany | Research Site | Berlin | |
Germany | Research Site | Emmendingen | |
Germany | Research Site | Kirchheim | Teck |
Germany | Research Site | Leipzig | |
Germany | Research Site | Luebeck | |
Germany | Research Site | Mannheim | |
Germany | Research Site | Muenchen | |
Germany | Research Site | Planegg | Muenchen |
Germany | Research Site | Reutlingen | |
Hong Kong | Research Site | Hong Kong | |
Hong Kong | Research Site | Shatin | |
Hong Kong | Research Site | Tuen Mun | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Debrecen | |
Hungary | Research Site | Miskolc | |
Hungary | Research Site | Nyiregyhaza | |
Hungary | Research Site | Szeged | |
India | Research Site | Bhopal | Madhya Pradesh |
India | Research Site | Bikaner | Rajasthan |
India | Research Site | Chandigarh | Punjab |
India | Research Site | Gujarat | |
India | Research Site | Jaipur | Rajasthan |
India | Research Site | Kolkota | West Bengal |
India | Research Site | Ludhiana | Punjab |
India | Research Site | Mumbai | Maharashtra |
India | Research Site | New Delhi | |
India | Research Site | Rohini | Delhi |
India | Research Site | Trivandrum | Kerala |
Italy | Research Site | Milan | |
Italy | Research Site | Rome | |
Japan | Research Site | Asahi-City | Chiba |
Japan | Research Site | Bunkyo-ku | Tokyo |
Japan | Research Site | Chiba-City | Chiba |
Japan | Research Site | Fuchu_city | Tokyo |
Japan | Research Site | Fukuoka-City | Fukuoka |
Japan | Research Site | Hamamatsu-city | Shizuoka |
Japan | Research Site | Itabashi-Ku | Tokyo |
Japan | Research Site | Kita-gun | Kagawa |
Japan | Research Site | Kobe-City | Hyogo |
Japan | Research Site | Kyoto-City | Kyoto |
Japan | Research Site | Maebashi-City | Gunma |
Japan | Research Site | Matsuyama-City | Ehime |
Japan | Research Site | Meguro-ku | Tokyo |
Japan | Research Site | Mitaka-City | Tokyo |
Japan | Research Site | Nagasaki | |
Japan | Research Site | Narashino-city | Chiba |
Japan | Research Site | Oita-City | Oita |
Japan | Research Site | Osaka-City | Osaka |
Japan | Research Site | Osaka-Sayama-City | Osaka |
Japan | Research Site | Otake-City | Hiroshima |
Japan | Research Site | Sagamihara-City | Kanagawa |
Japan | Research Site | Sapporo-City | Hokkaido |
Japan | Research Site | Sendai-City | Miyagi |
Japan | Research Site | Shinjuku-ku | Tokyo |
Japan | Research Site | Suita-City | Osaka |
Japan | Research Site | Sunto-gun | Shizuoka |
Japan | Research Site | Tsukuba-City | Ibaraki |
Japan | Research Site | Wako-City | Saitama |
Korea, Republic of | Research Site | Gangnam-gu | Seoul |
Korea, Republic of | Research Site | Heungduk-gu Cheongju | Chungbuk |
Korea, Republic of | Research Site | Seo-gu | Pusan |
Korea, Republic of | Research Site | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Research Site | Songpa-gu | Seoul |
Mexico | Research Site | Distrito Federal Ciudad | |
Mexico | Research Site | Metepec | Estado de Mexico |
Mexico | Research Site | Mexico City | |
Netherlands | Research Site | Amsterdam | |
Netherlands | Research Site | Eindhoven | |
Netherlands | Research Site | Groningen | |
Netherlands | Research Site | Nijmegen | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Koscierzyna | |
Poland | Research Site | Krakow | |
Poland | Research Site | Rzeszow | |
Poland | Research Site | Warszawa | |
Poland | Research Site | Wroclaw | |
Portugal | Research Site | Coimbra | |
Portugal | Research Site | Lisboa | |
Portugal | Research Site | Porto | |
Russian Federation | Research Site | Barnaul | |
Russian Federation | Research Site | Izhevsk | |
Russian Federation | Research Site | Kursk | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Sochi | |
Russian Federation | Research Site | St. Petersgurg | |
Russian Federation | Research Site | Stary Oskol | Belgorodskaya region |
Russian Federation | Research Site | Voronezh | |
Serbia | Research Site | Belgrade | |
Serbia | Research Site | Nis | |
Serbia | Research Site | Novi Sad | |
Singapore | Research Site | Singapore | |
South Africa | Research Site | Bloemfontein | |
South Africa | Research Site | Pietermaritzburg | |
South Africa | Research Site | Port Elizabeth | |
South Africa | Research Site | Tygerberg | Cape Town |
Sweden | Research Site | Goteborg | |
Sweden | Research Site | Gothenburg | |
Sweden | Research Site | Stockholm | |
Switzerland | Research Site | Basel | |
Switzerland | Research Site | Bern | |
Switzerland | Research Site | Locarno | |
Switzerland | Research Site | Sursee | |
Taiwan | Research Site | Kaohsiung | |
Taiwan | Research Site | Taipei | |
Taiwan | Research Site | Taoyuan | |
United Kingdom | Research Site | Cambridge | Cambridgeshire |
United Kingdom | Research Site | Huddersfield | Yorkshire |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Maidstone | Kent |
United Kingdom | Research Site | Reading | Berkshire |
United States | Research Site | Burlington | Vermont |
United States | Research Site | Canton | Ohio |
United States | Research Site | Des Moines | Iowa |
United States | Research Site | Gainsville | Florida |
United States | Research Site | Greenbrae | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Milwaukee | Wisconsin |
United States | Research Site | Nashville | Tennessee |
United States | Research Site | Norfolk | Virginia |
United States | Research Site | Norwich | Connecticut |
United States | Research Site | Palm Springs | California |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Port St.Lucie | Florida |
United States | Research Site | Salt Lake City | Utah |
United States | Research Site | San Mateo | California |
United States | Research Site | Seattle | Washington |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Washington | District of Columbia |
United States | Research Site | Wheeling | West Virginia |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Serbia, Singapore, South Africa, Sweden, Switzerland, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | Median time (in months) from randomisation until death using the Kaplan-Meier method | From date of randomization until date of death, assessed up to 32 months | No |
Secondary | Progression Free Survival | Median time (in months) from randomisation until clinical progression of disease, 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, using the Kaplan-Meier method | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months | No |
Secondary | Time to Use of Opiates | Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration =1 week using the Kaplan-Meier method | From date of randomization until use of opiates for disease-related symptoms for a duration =1 week, assessed up to 31 months | No |
Secondary | Incidence of Skeletal Related Events | Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method. | From date of randomization until occurrence of a skeletal related event, assessed up to 31 months | No |
Secondary | Bone Metastases Formation | Median time (in months) from randomisation to appearance of =4 new bone lesions using the Kaplan-Meier method | Patients were assessed every 12 weeks | No |
Secondary | Health Related Quality of Life | Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits. | Patients were assessed at every visit | No |
Secondary | Time to Prostate-specific Antigen (PSA) Progression | Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method. | Patients were assessed every 12 weeks | No |
Secondary | Time to Pain Progression | Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of =1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery. | Patients were assessed every 12 weeks | No |
Secondary | Time to Initiation of Chemotherapy | Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method | Patients were assessed every 12 weeks | No |
Secondary | Pharmacokinetic Characteristics of ZD4054 | PK samples were performed at randomisation, Week 4, Week 8 and Week 12 | No |
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