Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01191099
First received: August 25, 2010
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

A single-center cohort study to identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancer


Condition Intervention Phase
Prostate Cancer
Device: Pimonidazol
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Biospecimen Retention:   Samples With DNA

prostate


Estimated Enrollment: 150
Study Start Date: August 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pimonidazol
    0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy
    Other Name: Hypoxyprobe
Detailed Description:
  1. To perform a large scale assessment of tissue hypoxia by pimonidazole and hypoxia marker gene expression in human prostate cancers
  2. To characterize expression and hypoxia/HIF-responsiveness of myoglobin, cytoglobin, α-hemoglobin in prostate tumors and cell lines
  3. To identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancers
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich

Criteria

Inclusion criteria:

  • Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich
  • Written informed consent

Exclusion criteria:

  • Metastatic prostate cancer
  • Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product
  • Severe heart or lung disease
  • Severe liver or kidney dysfunction
  • Severe stridor
  • Distant metastases
  • Concurrent treatment for other malignant disease
  • Prior hormonal therapy or radiotherapy
  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: NCT01191099

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
University Hospital Zürich Recruiting
Zurich, Switzerland, 8091
Contact: Michael Müntener, MD    0041 44 255 11 11    michael.muentener@usz.ch   
Principal Investigator: Michael Müntener, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Michael Müntener, MD University Hospital Zurich, Division of urology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01191099     History of Changes
Other Study ID Numbers: xxx
Study First Received: August 25, 2010
Last Updated: November 7, 2011
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on October 23, 2014