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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
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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
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Secondary ID [1]
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0
D4320C00015
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Universal Trial Number (UTN)
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Trial acronym
ENTHUSE M0
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival
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Assessment method [1]
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Number of participants who have died at early analysis data cut off (DCO)
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Timepoint [1]
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From date of randomization until date of death, assessed up to 33 months
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Primary outcome [2]
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Progression Free Survival
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Assessment method [2]
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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
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Timepoint [2]
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Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
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Secondary outcome [1]
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Health Related Quality of Life
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Assessment method [1]
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Timepoint [1]
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Secondary outcome [2]
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Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [2]
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Timepoint [2]
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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Secondary outcome [3]
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Time to Symptomatic Progression
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Assessment method [3]
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Timepoint [3]
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Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
2577
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Research Site - Darlinghurst
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- Darlinghurst
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- Hornsby
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- Wollongong
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- Wodonga
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- Nedlands
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- Sydney
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Recruitment outside Australia
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Newcastle upon Tyne
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Funding & Sponsors
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Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00626548
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Contacts
Principal investigator
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Kurt Miller, Prof., M.D.
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Charite University, Berlin, Germany
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Results are available at
https://clinicaltrials.gov/study/NCT00626548
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