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

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ClinicalTrials.gov Identifier: NCT01191099
Recruitment Status : Recruiting
First Posted : August 30, 2010
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
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 or disease Intervention/treatment
Prostate Cancer Device: Pimonidazol

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

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance
Study Start Date : August 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources


Intervention Details:
    Device: Pimonidazol
    0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy
    Other Name: Hypoxyprobe


Biospecimen Retention:   Samples With DNA
prostate


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

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

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01191099     History of Changes
First Posted: August 30, 2010    Key Record Dates
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