Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

September 12, 2006 updated by: Kaunas University of Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Lithuania
      • Kaunas, Lithuania, 50009
        • Recruiting
        • Urology dep. of Kaunas University of Medicine
        • Contact:
        • Principal Investigator:
          • Mindaugas Jievaltas, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
quality of life
PSA dinamics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaunas University of Medicine

Investigators

  • Principal Investigator: Mindaugas Jievaltas, MD, PhD, Urology dep. of Kaunas University of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion

January 1, 2020

Study Registration Dates

First Submitted

September 12, 2006

First Submitted That Met QC Criteria

September 12, 2006

First Posted (Estimate)

September 13, 2006

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 12, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU-Urol1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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