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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01191099
• Status: Recruiting
• Phase: Phase 3
• First received: August 25, 2010
• Last updated: November 7, 2011
• Start date: August 2010
• Est. completion date: August 2020

Study information

• Verified date: November 2011
• Source: University of Zurich
• Contact: 01 Studienregister MasterAdmins
• Phone: +41 (0)44 255 11 11
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2020
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,