Skip to main content
Clinical Trials/NCT00796874
NCT00796874
Withdrawn
Not Applicable

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

ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Roswell Park Cancer Institute
Primary Endpoint
Prostate cancer progression measured by MRI while on active surveillance
Status
Withdrawn
Last Updated
12 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
July 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prostate cancer progression measured by MRI while on active surveillance

Time Frame: at 6 months, 1 year and than annualy for 5 years

Secondary Outcomes

  • Prostate cancer changes by MRI(At 6months, 1 year and annually for 5 years)

Similar Trials