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

NCT ID: NCT01191099

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2020-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pimonidazol

0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy

Intervention Type DEVICE

Other Intervention Names

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Hypoxyprobe

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Michael Müntener, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of urology

Locations

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University Hospital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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01 Studienregister MasterAdmins

Role: CONTACT

+41 (0)44 255 11 11

Facility Contacts

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Michael Müntener, MD

Role: primary

0041 44 255 11 11