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

Prostatic Neoplasms Clinical Trial

Official title:

Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152789
• Other study ID #: UHN REB 01-0102-C
• Status: Completed
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: August 7, 2009
• Start date: April 2001
• Est. completion date: March 2008

Study information

• Verified date: January 2008
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• Oxygen measurement - Eppendorf machine

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy		7 years	No
Secondary	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	No