NCT00796874

Magnetic Resonance Imaging in Detecting Cancer Progression in Patients With Early Stage Prostate Cancer Undergoing Active Surveillance

MR Imaging to Stratify Prostate Cancer Progression Risk in Patients on Active Surveillance

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
OTHER	active surveillance	Correlative Study
OTHER	imaging biomarker analysis	Correlative Study
PROCEDURE	biopsy	Tissue Removal
PROCEDURE	dynamic contrast-enhanced magnetic resonance imaging	Radiolical Medical Imaging
PROCEDURE	magnetic resonance imaging	Radiolical Medical Imaging
PROCEDURE	magnetic resonance spectroscopic imaging	Radiolical Medical Imaging

Timeline

• Start date: 2008-10-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2008-11-24
• Last updated: 2013-07-25