MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance
OBJECTIVES:
Primary
- To determine if MRI parameters (initial volume, number and location of image
abnormalities, and MR spectroscopy) can improve the ability to stratify cancer
progression risk in patients undergoing active surveillance for early-stage prostate
cancer.
Secondary
- Determine if changes in non-invasive MRI, validated by MRI-guided biopsies, can
accurately detect progression of prostate cancer.
OUTLINE: Patients undergo prostate MRI scans and MRI-guided biopsies of suspicious lesions
at baseline. Patients undergo conventional anatomic imaging followed by research biological
imaging tests (e.g., magnetic resonance spectroscopic imaging and/or dynamic
contrast-enhanced MRI). MRI are repeated at 6 months, 1 year, and then annually until
initiation of definitive therapy or for a total of 5 years.
Tissue biopsy with MRI guidance is done at baseline and annually or as clinically indicated
based on change in rectal exam, PSA, or maybe done based on change in MR imaging (i.e., new
MR lesion or significant change [> 25% increase] in the size of a MR lesion).
Blood samples are collected at baseline and periodically during study for PSA tests.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Prostate cancer progression measured by MRI while on active surveillance
at 6 months, 1 year and than annualy for 5 years
No
Anurag K. Singh, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
CDR0000618738
NCT00796874
October 2008
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |