NCT01220427

Brief Summary

The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
Last Updated

March 3, 2016

Status Verified

August 1, 2010

First QC Date

October 12, 2010

Last Update Submit

March 2, 2016

Conditions

Prostate CancerRadical Prostatectomy

Keywords

high-risk prostate cancerradical prostatectomymicro-RNA

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival

    The patients will be followed in regular time intervals in accordance with the EAU-Guidelines (2010) and the S-3 Guideline for Prostate cancer of the German Urological Association. Data will be updated once yearly for until death.

    Yearly update until clinical progression

Secondary Outcomes (1)

  • Cancer specific survival

    Yearly update until death

Study Arms (1)

Clinical high-risk prostate cancer, radical prostatectomy

Eligibility Criteria

Age35 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University hospital, community hospital

You may qualify if:

  • Patients with clinically localised high risk prostate cancer (cT\>2, bx GS \>7, PSA \>20 ng/ml) scheduled for radical prostatectomy.

You may not qualify if:

  • Non high risk prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology and Pediatric Urology University Hospital Würzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

June 1, 2007

Last Updated

March 3, 2016

Record last verified: 2010-08

Locations

DE(1)