Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00375687
Recruitment Status : Recruiting
First Posted : September 13, 2006
Last Update Posted : September 13, 2006
Information provided by:
Kaunas University of Medicine

September 12, 2006
September 13, 2006
September 13, 2006
August 2005
Not Provided
Same as current
No Changes Posted
  • PSA dinamics
  • quality of life
Same as current
Not Provided
Not Provided
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
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Triptorelin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2020
Not Provided

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
Sexes Eligible for Study: Male
40 Years to 80 Years   (Adult, Senior)
Contact: Mindaugas Jievaltas, PhD +37068730659
Not Provided
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Kaunas University of Medicine
Not Provided
Principal Investigator: Mindaugas Jievaltas, MD, PhD Urology dep. of Kaunas University of Medicine
Kaunas University of Medicine
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP