Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Outcomes
Primary Outcomes
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy
Time Frame: 7 years
Secondary Outcomes
- 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)