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
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: Triptorelin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Kaunas University of Medicine:

Primary Outcome Measures:
  • Survival

Secondary Outcome Measures:
  • PSA dinamics
  • quality of life

Estimated Enrollment: 61
Study Start Date: August 2005
Estimated Study Completion Date: January 2020
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375687

Contacts
Contact: Mindaugas Jievaltas, PhD +37068730659 minjiev@yahoo.com

Locations
Lithuania
Urology dep. of Kaunas University of Medicine Recruiting
Kaunas, Lithuania, 50009
Contact: Mindaugas Jievaltas, MD, PhD    +37068730659    minjiev@Yahoo.com   
Principal Investigator: Mindaugas Jievaltas, MD, PhD         
Sponsors and Collaborators
Kaunas University of Medicine
Investigators
Principal Investigator: Mindaugas Jievaltas, MD, PhD Urology dep. of Kaunas University of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375687     History of Changes
Other Study ID Numbers: KMU-Urol1
Study First Received: September 12, 2006
Last Updated: September 12, 2006
Health Authority: Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Kaunas University of Medicine:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014