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

Phase 2
Completed
Conditions
Prostatic Neoplasms
Registration Number
NCT00152789
Lead Sponsor
University Health Network, Toronto
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
40
Inclusion Criteria
  • Men due to undergo sextant prostate biopsy
  • Serum PSA <10 ng/ml
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Exclusion Criteria
  • Previous diagnosis of prostate cancer
  • Inability to give informed consent
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy7 years
Secondary Outcome Measures
NameTimeMethod
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

Trial Locations

Locations (1)

Princess Margaret Hospital

🇨🇦

Toronto, Ontario, Canada

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