Status:
COMPLETED
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
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 providi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00676286
Start Date
November 1 2008
End Date
March 1 2016
Last Update
July 6 2016
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2