NCT00375687
Unknown
Not Applicable
Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
ConditionsProstate Cancer
DrugsTriptorelin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Kaunas University of Medicine
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Survival
- Last Updated
- 19 years ago
Overview
Brief Summary
The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.
Detailed Description
The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.
Investigators
Eligibility Criteria
Inclusion Criteria
- •preoperative PSA\>20ng/ml
- •postoperative PSA \>0.2 ng/ml
- •Gleason \> 7
- •signated infomed consent
Exclusion Criteria
- •neoadjuvant hormonaltherapy before RP
- •unstable cncomitant conditions
Outcomes
Primary Outcomes
Survival
Secondary Outcomes
- PSA dinamics
- quality of life
Study Sites (1)
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