Micro-RNA Expression Profiles in High Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Micro-RNA Expression Profiles in High Risk Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01220427
• Other study ID #: mi-RNA HR-Pca
• Status: Terminated
• Phase: N/A
• First received: October 12, 2010
• Last updated: March 2, 2016
• Start date: June 2007

Study information

• Verified date: August 2010
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Non high risk prostate cancer

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radical Prostatectomy

Locations

Country	Name	City	State
Germany	Department of Urology and Pediatric Urology University Hospital Würzburg	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cancer specific 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 until death.	Yearly update until death	No