Investigation of Early Hormonotherapy Efficacy of Prostat... | NCT00375687

Studies
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

NCT00375687

Sponsor

Kaunas University of Medicine

Status

Unknown status

Last Update Posted

Sep 13, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

Triptorelin

Countries

Lithuania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Jan 2020

First Submitted Date

Sep 12, 2006

First Submission Date that Met QC Criteria

Sep 12, 2006

First Posted Date

Sep 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2006

Last Update Posted Date

Sep 13, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Triptorelin	Drug

Measure	Description	Time Frame
Survival

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mindaugas Jievaltas, PhD	Contact	+37068730659		minjiev@yahoo.com

Overall Officials

Name	Affiliation	Role
Mindaugas Jievaltas, MD, PhD	Urology dep. of Kaunas University of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urology dep. of Kaunas University of Medicine	Recruiting	Kaunas		50009	Lithuania

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017329	Triptorelin Pamoate

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided