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Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

NCT ID: NCT00375687

Last Updated: 2006-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Keywords

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Prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Triptorelin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Kaunas University of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Mindaugas Jievaltas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Urology dep. of Kaunas University of Medicine

Locations

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Urology dep. of Kaunas University of Medicine

Kaunas, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Mindaugas Jievaltas, PhD

Role: CONTACT

Phone: +37068730659

Email: [email protected]

Facility Contacts

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Mindaugas Jievaltas, MD, PhD

Role: primary

Other Identifiers

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KMU-Urol1

Identifier Type: -

Identifier Source: org_study_id