Micro-RNA Expression Profiles in High Risk Prostate Cancer

This study has been terminated.
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by:
Wuerzburg University Hospital
ClinicalTrials.gov Identifier:
NCT01220427
First received: October 12, 2010
Last updated: March 2, 2016
Last verified: August 2010
  Purpose
The purpose of this study is to determine whether specific Micro-RNA expression profiles are related to Prostate cancer outcome.

Condition
Prostate Cancer
Radical Prostatectomy

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Micro-RNA Expression Profiles in High Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Wuerzburg University Hospital:

Primary Outcome Measures:
  • Recurrence free survival [ Time Frame: Yearly update until clinical progression ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cancer specific survival [ Time Frame: Yearly update until death ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: June 2007
Groups/Cohorts
Clinical high-risk prostate cancer, radical prostatectomy

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
University hospital, community hospital
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220427

Locations
Germany
Department of Urology and Pediatric Urology University Hospital Würzburg
Würzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital
Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: Martin Spahn, University Hospital Würzburg
ClinicalTrials.gov Identifier: NCT01220427     History of Changes
Other Study ID Numbers: mi-RNA HR-Pca 
Study First Received: October 12, 2010
Last Updated: March 2, 2016
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Wuerzburg University Hospital:
high-risk prostate cancer
radical prostatectomy
micro-RNA

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 24, 2016