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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00626548




Registration number
NCT00626548
Ethics application status
Date submitted
24/01/2008
Date registered
29/02/2008
Date last updated
3/09/2012

Titles & IDs
Public title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Scientific title
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
Secondary ID [1] 0 0
D4320C00015
Universal Trial Number (UTN)
Trial acronym
ENTHUSE M0
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZD4054
Treatment: Drugs - Palcebo

Placebo comparator: Placebo - Matching Placebo

Experimental: ZD4054 - ZD4054 (Zibotentan)


Treatment: Drugs: ZD4054
10 mg once daily oral dose

Treatment: Drugs: Palcebo
Matching Plcebo oral tablet once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From date of randomization until date of death, assessed up to 33 months
Primary outcome [2] 0 0
Progression Free Survival
Timepoint [2] 0 0
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [1] 0 0
Health Related Quality of Life
Timepoint [1] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [2] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [2] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Secondary outcome [3] 0 0
Time to Symptomatic Progression
Timepoint [3] 0 0
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
2577
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Hornsby
Recruitment hospital [3] 0 0
Research Site - Westmead
Recruitment hospital [4] 0 0
Research Site - Wollongong
Recruitment hospital [5] 0 0
Research Site - Wodonga
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - Sydney
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- Darlinghurst
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- Hornsby
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- Westmead
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- Wollongong
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- Wodonga
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- Nedlands
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- Sydney
Recruitment outside Australia
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Pretoria
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Alicante
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Spain
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Helsingborg
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Uppsala
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Switzerland
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Aarau
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Taipei
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Berkshire
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Hertfordshire
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kurt Miller, Prof., M.D.
Address 0 0
Charite University, Berlin, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00626548