Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19 in Prostate Cancer Using High Field MRI (3 Tesla), PET, and Biomarkers
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Procedure: 3T MR ImagingProcedure: C-Choline PET ScanningProcedure: Gene Rearrangement
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.
Primary objective to determine if we can accrue patients to this study in a timely manner. [ Time Frame: 2 years ]
Secondary Outcome Measures
Patient compliance [ Time Frame: Patients followed for 5 years from baseline ]
Optimal imaging parameters to characterize prostate cancers [ Time Frame: patients followed for 5 years from baseline ]
feasibility of detecting gene arrangements in prostate biopsies [ Time Frame: patients followed for 5 years from baseline ]
Incidence of patients developing progressive prostate cancer warranting definitive treatment in an active surveillance protocol [ Time Frame: patients followe for 5 years from baseline ]
The natural history of prostate cancer with these investigations [ Time Frame: patients followed for 5 years from baseline ]
The sensitivity and specificity of these investigation in detecting prostate cancer [ Time Frame: patients followed for 5 years from baseline ]
The sensitivity and specificity of these investigations in differentiating indolent prostate cancer from aggressive disease [ Time Frame: 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 [ Time Frame: patients followed for 5 years from baseline ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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