Back to resultsNormal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
Primary Purpose
Prostatic Neoplasms
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Oxygen measurement - Eppendorf machine
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasms
Eligibility Criteria
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
Sites / Locations
- Princess Margaret Hospital
Outcomes
Primary Outcome Measures
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00152789
First Posted
September 7, 2005
Last Updated
August 7, 2009
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00152789
Brief Title
Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
Official Title
Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Oxygen measurement - Eppendorf machine
Primary Outcome Measure Information:
Title
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
Time Frame
7 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
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