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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152789
First received: September 7, 2005
Last updated: August 7, 2009
Last verified: January 2008
History of Changes
  Purpose

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 Intervention Phase
Prostatic Neoplasms
 Procedure: Oxygen measurement - Eppendorf machine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy [ Time Frame: 7 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2001
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152789

Locations
Canada, Ontario
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
  More Information

No publications provided

Responsible Party: Dr. Michael Milosevic, Principal Investigator, University Health Network
ClinicalTrials.gov Identifier: NCT00152789     History of Changes
Other Study ID Numbers: UHN REB 01-0102-C
Study First Received: September 7, 2005
Last Updated: August 7, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 22, 2013