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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00375687 |
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Date of registration:
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12/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
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Scientific title:
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Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy |
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Date of first enrolment:
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August 2005 |
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Target sample size:
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61 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00375687 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Mindaugas Jievaltas, PhD |
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Address:
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Telephone:
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+37068730659 |
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Email:
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minjiev@yahoo.com |
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Affiliation:
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Name:
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Mindaugas Jievaltas, MD, PhD |
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Address:
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Telephone:
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+37068730659 |
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Email:
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minjiev@Yahoo.com |
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Affiliation:
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Name:
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Mindaugas Jievaltas, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Urology dep. of Kaunas University of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- preoperative PSA>20ng/ml
- postoperative PSA >0.2 ng/ml
- Gleason > 7
- pT3b
- signated infomed consent
Exclusion Criteria:
- neoadjuvant hormonaltherapy before RP
- R1 RP
- N+ RP
- unstable cncomitant conditions
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Triptorelin
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Primary Outcome(s)
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Survival
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Secondary Outcome(s)
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PSA dinamics
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quality of life
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Secondary ID(s)
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KMU-Urol1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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