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

This study is currently recruiting participants.
Verified November 2011 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191099
First Posted: August 30, 2010
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01191099     History of Changes
First Submitted: August 25, 2010
First Posted: August 30, 2010
Last Update Posted: November 8, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Prostatic Neoplasms
Hypoxia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms