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Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00375687
Enrollment
61
Registered
2006-09-13
Start date
2005-08-31
Completion date
2020-01-31
Last updated
2006-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer

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.

Interventions

DRUGTriptorelin

Sponsors

Kaunas University of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Survival—

Secondary

MeasureTime frame
PSA dinamics—
quality of life—

Countries

Lithuania

Contacts

Primary ContactMindaugas Jievaltas, PhD
minjiev@yahoo.com+37068730659

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026