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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
M00-211
Universal Trial Number (UTN)
Trial acronym
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of this study is to evaluate safety and efficacy as measured by time-to-disease progression
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Diagnosis of prostate cancer.
* Rising PSA while on hormonal therapy or following surgical castration.
* Documented evidence of metastatic disease.
Minimum age
19 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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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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Repatriation General Hospital - Daws Park
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Peter Maccallum Cancer Institute - East Melbourne
Recruitment hospital [7] 0 0
Bayside Urology - Mentone
Recruitment hospital [8] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [9] 0 0
Hollywood Specialist Centre - Nedlands
Recruitment hospital [10] 0 0
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
Recruitment postcode(s) [10] 0 0
QLD 4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being done to evaluate the safety and efficacy of atrasentan in men with metastatic hormone-refractory prostate cancer.
Trial website
https://clinicaltrials.gov/study/NCT00036543
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Darryl Sleep, M.D.
Address 0 0
Abbott
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00036543