Trial | NCT00375687  Report issue

Title

Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    61
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.
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 Started
Aug 31
2005
Study Completion
Jan 31
2020
Last Update
Sep 13
2006
Estimate

Drug Triptorelin

Criteria 

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
No Results Posted