Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
18 Years
N/A
Male
Prostate Cancer
Trial Information
Biological Investigations in Active Surveillance (BIAS) IGAR 2008 I 19
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
Primary objective to determine if we can accrue patients to this study in a timely manner.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Nawaid Usmani, MD, FRCPC
Investigator Role:
Study Chair
Investigator Affiliation:
Cross Cancer Institute
Authority:
Canada: Health Canada
Study ID:
GU-24152
NCT ID:
NCT00676286
Start Date:
November 2008
Completion Date:
August 2014
Related Keywords:
- Prostate Cancer
- Prostate cancer active surveillance
- 3 Tesla MR biological imaging in prostate cancer
- tumor gene re-arrangements in prostate cancer
- Prostatic Neoplasms
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