Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy
This study has been completed.
Sponsor:
University Health Network, Toronto
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152789
First received: September 7, 2005
Last updated: August 7, 2009
Last verified: January 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 7, 2005 | ||||
| Last Updated Date | August 7, 2009 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy [ Time Frame: 7 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Median pO2 and HP5 will be analyzed according to the presence or absence of tumour on biopsy | ||||
| Change History | Complete list of historical versions of study NCT00152789 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: 7 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Normal Prostate: Oxygenation of the Prostate Gland in Men Undergoing Prostate Biopsy | ||||
| Official Title ICMJE | Oxygenation of the Prostate Gland: a Polarographic Electrode Study in Men Undergoing Prostate Biopsy. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Prostatic Neoplasms | ||||
| Intervention ICMJE | Procedure: Oxygen measurement - Eppendorf machine | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00152789 | ||||
| Other Study ID Numbers ICMJE | UHN REB 01-0102-C | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr. Michael Milosevic, Principal Investigator, University Health Network | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Princess Margaret Hospital, Canada | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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