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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00152789
Enrollment
40
Registered
2005-09-09
Start date
2001-04-30
Completion date
2008-03-31
Last updated
2009-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms

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.

Interventions

PROCEDUREOxygen measurement - Eppendorf machine

Sponsors

Princess Margaret Hospital, Canada
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy7 years

Secondary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026