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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00152789
Collaborator
Princess Margaret Hospital, Canada (Other)
40
Enrollment
1
Location
83
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Oxygen measurement - Eppendorf machine
 Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2001
Actual Primary Completion Date :
Mar 1, 2008
Actual Study Completion Date :
Mar 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy [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. [7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto
  • Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Michael Milosevic, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00152789
Other Study ID Numbers:
  • UHN REB 01-0102-C
First Posted:
Sep 9, 2005
Last Update Posted:
Aug 10, 2009
Last Verified:
Jan 1, 2008
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 10, 2009