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

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University Health Network, Toronto

Status and phase

Completed
Phase 2

Conditions

Prostatic Neoplasms

Treatments

Procedure: Oxygen measurement - Eppendorf machine

Study type

Interventional

Funder types

Other

Identifiers

NCT00152789
UHN REB 01-0102-C

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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