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Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer After Radical Prostatectomy


N/A
40 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Investigation of Early Hormonotherapy Efficacy of High Risk Patients for Progression of Prostate Cancer 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Survival

Principal Investigator

Mindaugas Jievaltas, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Urology dep. of Kaunas University of Medicine

Authority:

Lithuania: State Medicine Control Agency - Ministry of Health

Study ID:

KMU-Urol1

NCT ID:

NCT00375687

Start Date:

August 2005

Completion Date:

January 2020

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Prostatic Neoplasms

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