NCT00375687

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
13.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 13, 2006

Status Verified

November 1, 2005

First QC Date

September 12, 2006

Last Update Submit

September 12, 2006

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Survival

Secondary Outcomes (2)

  • PSA dinamics

  • quality of life

Interventions

TriptorelinDRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • preoperative PSA\>20ng/ml
  • postoperative PSA \>0.2 ng/ml
  • Gleason \> 7
  • pT3b
  • signated infomed consent

You may not qualify if:

  • neoadjuvant hormonaltherapy before RP
  • R1 RP
  • N+ RP
  • unstable cncomitant conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology dep. of Kaunas University of Medicine

Kaunas, 50009, Lithuania

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Mindaugas Jievaltas, MD, PhD

    Urology dep. of Kaunas University of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindaugas Jievaltas, PhD

CONTACT

+37068730659minjiev@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

August 1, 2005

Study Completion

January 1, 2020

Last Updated

September 13, 2006

Record last verified: 2005-11

Locations

LI(1)