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

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152789

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 II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.

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

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.

Estimated Enrollment:	40
Study Start Date:	April 2001

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

Contacts

Contact: Michael Milosevic, MD

416-946-2124

michael.milosevic@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD 416-946-2124 michael.milosevic@rmp.uhn.on.ca
Principal Investigator: Michael Milosevic, MD

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Michael Milosevic, MD

Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 01-0102-C
Study First Received:	September 7, 2005
Last Updated:	January 30, 2006
ClinicalTrials.gov Identifier:	NCT00152789
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009