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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00554229
Registration number
NCT00554229
Ethics application status
Date submitted
2/11/2007
Date registered
6/11/2007
Date last updated
8/02/2016
Titles & IDs
Public title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
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Scientific 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.
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Secondary ID [1]
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0
2007-003227-20
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Secondary ID [2]
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D4320C00014
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Universal Trial Number (UTN)
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Trial acronym
ENTHUSE M1
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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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Condition category
Condition code
Cancer
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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 - Placebo
Experimental: ZD4054 - ZD4054 10 mg oral tablet once daily
Placebo comparator: Placebo - Matching Placebo, oral tablets once daily
Treatment: Drugs: ZD4054
ZD4054 10 mg oral tablet once daily
Treatment: Drugs: Placebo
Matching placebo oral tablet once daily
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Intervention code [1]
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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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Median time (in months) from randomisation until death using the Kaplan-Meier method
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Timepoint [1]
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From date of randomization until date of death, assessed up to 32 months
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Secondary outcome [1]
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Progression Free Survival
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Assessment method [1]
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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
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Timepoint [1]
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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
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Secondary outcome [2]
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Time to Use of Opiates
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Assessment method [2]
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Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration =1 week using the Kaplan-Meier method
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Timepoint [2]
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From date of randomization until use of opiates for disease-related symptoms for a duration =1 week, assessed up to 31 months
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Secondary outcome [3]
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Incidence of Skeletal Related Events
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Assessment method [3]
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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.
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Timepoint [3]
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From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
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Secondary outcome [4]
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Bone Metastases Formation
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Assessment method [4]
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Median time (in months) from randomisation to appearance of =4 new bone lesions using the Kaplan-Meier method
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Timepoint [4]
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Patients were assessed every 12 weeks
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Secondary outcome [5]
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Health Related Quality of Life
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Assessment method [5]
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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.
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Timepoint [5]
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Patients were assessed at every visit
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Secondary outcome [6]
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Time to Prostate-specific Antigen (PSA) Progression
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Assessment method [6]
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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.
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Timepoint [6]
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Patients were assessed every 12 weeks
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Secondary outcome [7]
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Time to Pain Progression
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Assessment method [7]
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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.
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Timepoint [7]
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Patients were assessed every 12 weeks
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Secondary outcome [8]
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Time to Initiation of Chemotherapy
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Assessment method [8]
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Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method
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Timepoint [8]
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Patients were assessed every 12 weeks
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Secondary outcome [9]
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Pharmacokinetic Characteristics of ZD4054
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Assessment method [9]
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Timepoint [9]
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PK samples were performed at randomisation, Week 4, Week 8 and Week 12
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Eligibility
Key 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
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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 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
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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 assessing the outcomes
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
Completed
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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
1/11/2007
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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
1/08/2011
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Sample size
Target
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Accrual to date
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Final
896
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Research Site - Hornsby
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- Hornsby
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- St Leonards
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- Redcliffe
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- Ashford
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- Subiaco
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Funding & Sponsors
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AstraZeneca
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00554229
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Contacts
Principal investigator
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Martin Gleave, MD, FRCSC, FACS
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The Prostate Centre at Vancouver General Hospital
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Results are available at
https://clinicaltrials.gov/study/NCT00554229
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