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

NCT ID: NCT00152789

Last Updated: 2009-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2008-03-31

Brief Summary

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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

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Oxygen measurement - Eppendorf machine

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Health Network

Principal Investigators

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Michael Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

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Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 01-0102-C

Identifier Type: -

Identifier Source: org_study_id

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