Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
3T MR Imaging
C-Choline PET Scanning
Gene Rearrangement
Sponsored by
About this trial
This is an interventional screening trial for Prostate Cancer focused on measuring Prostate cancer active surveillance, 3 Tesla MR biological imaging in prostate cancer, tumor gene re-arrangements in prostate cancer
Eligibility Criteria
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
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
Primary objective to determine if we can accrue patients to this study in a timely manner.
Secondary Outcome Measures
Patient compliance
Optimal imaging parameters to characterize prostate cancers
feasibility of detecting gene arrangements in prostate biopsies
Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol
The natural history of prostate cancer with these investigations
The sensitivity and specificity of these investigation in detecting prostate cancer
The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease
The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00676286
Brief Title
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
Official Title
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer active surveillance, 3 Tesla MR biological imaging in prostate cancer, tumor gene re-arrangements in prostate cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
3T MR Imaging
Intervention Description
3TR Imaging
Intervention Type
Procedure
Intervention Name(s)
C-Choline PET Scanning
Intervention Description
C-Choline PET Scanning
Intervention Type
Procedure
Intervention Name(s)
Gene Rearrangement
Intervention Description
Gene Rearrangement
Primary Outcome Measure Information:
Title
Primary objective to determine if we can accrue patients to this study in a timely manner.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient compliance
Time Frame
Patients followed for 5 years from baseline
Title
Optimal imaging parameters to characterize prostate cancers
Time Frame
patients followed for 5 years from baseline
Title
feasibility of detecting gene arrangements in prostate biopsies
Time Frame
patients followed for 5 years from baseline
Title
Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol
Time Frame
patients followe for 5 years from baseline
Title
The natural history of prostate cancer with these investigations
Time Frame
patients followed for 5 years from baseline
Title
The sensitivity and specificity of these investigation in detecting prostate cancer
Time Frame
patients followed for 5 years from baseline
Title
The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease
Time Frame
patients followed for 5 years from baseline
Title
The sensitivity and specificity of these investigations in detecting high grade disease, extracapsular disease and extraprostatic disease and disease progression
Time Frame
patients followed for 5 years from baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawaid Usmani, MD, FRCPC
Organizational Affiliation
Cross Cancer Institute
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nawaid Usmani, MD, FRCPC
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
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