Back to resultsInvestigation of Early Hormonotherapy Efficacy of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Triptorelin
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer
Eligibility 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
Sites / Locations
- Urology dep. of Kaunas University of MedicineRecruiting
Outcomes
Primary Outcome Measures
Survival
Secondary Outcome Measures
PSA dinamics
quality of life
Full Information
NCT ID
NCT00375687
First Posted
September 12, 2006
Last Updated
September 12, 2006
Sponsor
Kaunas University of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00375687
Brief Title
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
Official Title
Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2020 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kaunas University of Medicine
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Triptorelin
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
PSA dinamics
Title
quality of life
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mindaugas Jievaltas, PhD
Phone
+37068730659
Email
minjiev@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mindaugas Jievaltas, MD, PhD
Organizational Affiliation
Urology dep. of Kaunas University of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology dep. of Kaunas University of Medicine
City
Kaunas
ZIP/Postal Code
50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mindaugas Jievaltas, MD, PhD
Phone
+37068730659
Email
minjiev@Yahoo.com
First Name & Middle Initial & Last Name & Degree
Mindaugas Jievaltas, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer
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