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Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152789
First Posted: September 9, 2005
Last Update Posted: August 10, 2009
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. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
September 7, 2005
September 9, 2005
August 10, 2009
April 2001
March 2008   (Final data collection date for primary outcome measure)
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy [ Time Frame: 7 years ]
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
Complete list of historical versions of study NCT00152789 on ClinicalTrials.gov Archive Site
Median pO2 and HP5 for the prostate gland in each patient with negative biopsy result will be compared with the median pO2 and HP5 for peri-prostatic tissue. [ Time Frame: 7 years ]
Median pO2 and HP5 for the prostate gland in each patient with negative biopsy result will be compared with the median pO2 and HP5 for peri-prostatic tissue.
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Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.
This study is based on previous observation that, in men with localized prostate cancer, non-cancerous prostate tissue is hypoxic, and on the known contribution of hypoxia to the progression of cancer. Patients undergoing diagnostic prostate biopsy with serum prostate specific antigen (PSA) less than 10ng/ml and who have given informed consent will have oxygen measurements of the prostate and peri-prostatic tissue taken with the Eppendorf electrode at the time of biopsy. The oxygenation of normal prostate tissue will be compared to that of cancerous prostate tissue. In men with negative biopsies, the prostate tissue oxygen measurements will be compared with the peri-prostatic tissue oxygen measurements.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prostatic Neoplasms
Procedure: Oxygen measurement - Eppendorf machine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men due to undergo sextant prostate biopsy
  • Serum PSA <10 ng/ml

Exclusion Criteria:

  • Previous diagnosis of prostate cancer
  • Inability to give informed consent
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00152789
UHN REB 01-0102-C
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Not Provided
Not Provided
Dr. Michael Milosevic, Principal Investigator, University Health Network
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, Canada
University Health Network, Toronto
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP