Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

Kaunas University of Medicine61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

TriptorelinDRUG

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Urology dep. of Kaunas University of Medicine

Kaunas, Lithuania

RECRUITING

Outcomes

Primary Outcomes

Survival

Secondary Outcomes

PSA dinamics

quality of life

Central Contacts

Mindaugas Jievaltas, PhD

CONTACT

+37068730659 minjiev@yahoo.com

Data from ClinicalTrials.gov

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