Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
Not Applicable
- Conditions
- Prostate Cancer
- Registration Number
- NCT00375687
- Lead Sponsor
- Kaunas University of Medicine
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- preoperative PSA>20ng/ml
- postoperative PSA >0.2 ng/ml
- Gleason > 7
- pT3b
- signated infomed consent
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Exclusion Criteria
- neoadjuvant hormonaltherapy before RP
- R1 RP
- N+ RP
- unstable cncomitant conditions
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival
- Secondary Outcome Measures
Name Time Method PSA dinamics quality of life
Trial Locations
- Locations (1)
Urology dep. of Kaunas University of Medicine
🇱🇹Kaunas, Lithuania