NCT00375687UnknownNot Applicable
Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
Kaunas University of Medicine1 site in 1 country61 target enrollmentStarted: August 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Survival
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Investigators
Study Sites (1)
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