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

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. Identifier: NCT00152789
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : August 10, 2009
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Procedure: Oxygen measurement - Eppendorf machine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.
Study Start Date : April 2001
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00152789

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: Michael Milosevic, MD Princess Margaret Hospital, Canada

Responsible Party: Dr. Michael Milosevic, Principal Investigator, University Health Network Identifier: NCT00152789     History of Changes
Other Study ID Numbers: UHN REB 01-0102-C
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: August 10, 2009
Last Verified: January 2008

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases