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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/NCT00036556




Registration number
NCT00036556
Ethics application status
Date submitted
10/05/2002
Date registered
13/05/2002
Date last updated
15/08/2007

Titles & IDs
Public title
Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Scientific title
A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer
Secondary ID [1] 0 0
M00-244
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Treatment: Drugs: Atrasentan
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.
Timepoint [1] 0 0
Every 12 weeks

Eligibility
Key inclusion criteria
- Have been diagnosed with prostate cancer.

- Have a rising PSA while on hormone therapy or following surgical castration.
Minimum age
19 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Have evidence of distant metastatic disease on screening bone scan or CT scan.

- 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
1/06/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
941
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prince Of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Westmead Public Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane Hospital - Herston
Recruitment hospital [4] 0 0
Repatriation General Hospital - Daws Park
Recruitment hospital [5] 0 0
Peter Maccallum Cancer Institute - East Melbourne
Recruitment hospital [6] 0 0
Bayside Urology - Mentone
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5041 - Daws Park
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3194 - Mentone
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3050 - Parkville
Recruitment postcode(s) [8] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
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Alabama
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Southampton

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
non-metastatic hormone-refractory prostate cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00036556
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gary Gordon, 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/ct2/show/NCT00036556