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Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2005 by Kaunas University of Medicine
Sponsor:
Information provided by:
Kaunas University of Medicine
ClinicalTrials.gov Identifier:
NCT00375687
First received: September 12, 2006
Last updated: NA
Last verified: November 2005
History: No changes posted

September 12, 2006
September 12, 2006
August 2005
Not Provided
Survival
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
61
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
Male
40 Years to 80 Years
No
Contact: Mindaugas Jievaltas, PhD +37068730659 minjiev@yahoo.com
Lithuania
 
NCT00375687
KMU-Urol1
Not Provided
Not Provided
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