Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers

Study Overview
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Brief Summary
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This study will use high field MRI (3 Tesla), PET and biomarker to follow prostate cancers and determine if these tests can detect cancers that become aggressive.

Detailed Description
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This study may lead to the identification of additional investigations that can monitor for signs of disease progression in active surveillance protocols. This can directly benefit patients by providing them with greater confidence that their disease is being accurately monitored. In addition, this study may be beneficial to the general management of prostate cancers by adding to our knowledge of these investigations characterizing prostate cancers.

Official Title
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Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: 3T MR Imaging
* Procedure: C-Choline PET Scanning
* Procedure: Gene Rearrangement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven adenocarcinoma of the prostate Registration must occur within 16 weeks of last biopsy History and physical exam (including DRE) within 8 weeks prior to registration Patients must have indolent prostate cancer including all of the following: Low risk prostate cancer, less or equal to 50 % of core biopsies involved with disease, and less or equal to three biopsies involved with disease Patients must have a minimum of six biopsies (sextant) at registration PSA test within 8 weeks registration Creatinine level below 100 umol/L within 8 weeks of registration Patients must have no contraindications to MRI scans No history of previous malignancies except non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy Patients must be reliable for follow up Exclusion Criteria: Patient does not have histologically-proven adenocarcinoma of the prostate Last biopsy greater than 16 weeks prior to registration History and physical exam (including DRE) greater that 8 weeks prior to registration Patient does not have indolent disease Patient has less than six sextant biopsies at registration PSA test done greater than 8 weeks from registration Creatinine level greater than 100 umol/L within 8 weeks of registration Contraindications to MRI scans History of previous malignancies other than non-melanoma skin tumors or other malignancies with a greater than 5 year life expectancy Patients that are not reliable for follow up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 3T MR Imaging|3TR Imaging|
|Procedure: C-Choline PET Scanning|C-Choline PET Scanning|
|Procedure: Gene Rearrangement|Gene Rearrangement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective to determine if we can accrue patients to this study in a timely manner. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient compliance |  | Patients followed for 5 years from baseline | 
| Optimal imaging parameters to characterize prostate cancers |  | patients followed for 5 years from baseline | 
| feasibility of detecting gene arrangements in prostate biopsies |  | patients followed for 5 years from baseline | 
| Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol |  | patients followe for 5 years from baseline | 
| The natural history of prostate cancer with these investigations |  | patients followed for 5 years from baseline | 
| The sensitivity and specificity of these investigation in detecting prostate cancer |  | patients followed for 5 years from baseline | 
| The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease |  | patients followed for 5 years from baseline | 
| The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression |  | patients followed for 5 years from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer active surveillance, 3 Tesla MR biological imaging in prostate cancer, tumor gene re-arrangements in prostate cancer