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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00036543
Registration number
NCT00036543
Ethics application status
Date submitted
10/05/2002
Date registered
13/05/2002
Date last updated
15/08/2006
Titles & IDs
Public title
A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
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Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of 10 Mg Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
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Secondary ID [1]
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0
M00-211
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Universal Trial Number (UTN)
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Trial acronym
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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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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atrasentan
Treatment: Drugs: Atrasentan
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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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The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Diagnosis of prostate cancer.
- Rising PSA while on hormonal therapy or following surgical castration.
- Documented evidence of metastatic disease.
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Minimum age
19
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
- Have received cytotoxic chemotherapy.
- Have received opioid or narcotic medications (such as codeine or morphine) or
radiation for pain caused by your prostate cancer in the last 6 months.
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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?
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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
1/05/2001
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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
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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St Vincent's Clinic - Darlinghurst
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Prince Of Wales Hospital - Randwick
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Westmead Public Hospital - Westmead
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Royal Brisbane Hospital - Herston
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Recruitment hospital [5]
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Repatriation General Hospital - Daws Park
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Recruitment hospital [6]
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Peter Maccallum Cancer Institute - East Melbourne
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Bayside Urology - Mentone
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Royal Melbourne Hospital - Parkville
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Hollywood Specialist Centre - Nedlands
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Princess Alexandra Hospital - Woolloongabba
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2010 - Darlinghurst
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2031 - Randwick
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2145 - Westmead
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4029 - Herston
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5041 - Daws Park
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3002 - East Melbourne
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3194 - Mentone
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3050 - Parkville
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6009 - Nedlands
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QLD 4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott
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Address
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Ethics approval
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Summary
Brief summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with
metastatic hormone-refractory prostate cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00036543
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Darryl Sleep, M.D.
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Address
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Abbott
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00036543
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