Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance
|ClinicalTrials.gov Identifier: NCT00796874|
Recruitment Status : Withdrawn (PI decided to terminate study.)
First Posted : November 24, 2008
Last Update Posted : July 25, 2013
RATIONALE: Sometimes prostate cancer may not need treatment until it progresses. In this case, active surveillance may be sufficient. Diagnostic procedures, such as magnetic resonance imaging, may be a less invasive method of finding prostate cancer that has progressed.
PURPOSE: This clinical trial is studying how well magnetic resonance imaging works in detecting cancer progression in patients with early-stage prostate cancer who are undergoing active surveillance.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: active surveillance Other: imaging biomarker analysis Procedure: biopsy Procedure: dynamic contrast-enhanced magnetic resonance imaging Procedure: magnetic resonance imaging Procedure: magnetic resonance spectroscopic imaging||Not Applicable|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Other: active surveillance
- Prostate cancer progression measured by MRI while on active surveillance [ Time Frame: at 6 months, 1 year and than annualy for 5 years ]
- Prostate cancer changes by MRI [ Time Frame: At 6months, 1 year and annually for 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00796874
|Principal Investigator:||Anurag K. Singh, MD||Roswell Park Cancer Institute|