MRI/MRSI in Risk Assessment of Prostate Cancer Patients

October 14, 2011 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to see if magnetic resonance imaging (MRI) and magnetic resonance spectroscopic imaging (MRSI) can tell which patients with prostate cancer are at a low risk for their cancer growing and spreading. Magnetic resonance methods use magnets and radio waves to take pictures of body structure (MRI) and to measure amounts of important chemicals within the body (MRSI). This study will look at the structural and chemical properties of prostates before undergoing treatment. Hopefully, doctors will be able to use this method before making treatment decisions for patients with newly diagnosed cancer of the prostate. This study will continue our work to assess the value of MRI/MRSI in addressing what is currently one of the greatest clinical challenges in the management of prostate cancer: the identification of low-risk organ-confined prostate cancer that can be managed expectantly with deferred treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, patients with low-risk, organ-confined prostate cancer identified in clinic or prior to their already scheduled standard of care MRI in the Department of Radiology will be approached for the study. Eligible patients will undergo a baseline eMRI/MRSI exam between 6 and 24 weeks following biopsy. Patients will undergo definitive treatment (radical prostatectomy (RP) or radiation therapy (RT)) or will be placed on deferred therapy. Predictor variables will be recorded for each patient after enrollment, before treatment and during treatment follow-up. Patient outcome-disease progression will be determined by long term clinical follow-up

Study Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer
  2. Clinically low-risk localized disease as defined by NCCN guidelines (clinical stage T1-T2a, maximum Gleason score 2-6, peak serum PSA level < 10 ng/ml)
  3. No evidence of disseminated disease (bone or lymph node metastases)
  4. Treatment-radical prostatectomy, radiation therapy, or deferred therapy-will be at MSKCC
  5. Willingness to undergo serial surveillance TRUS-guided prostate biopsies and eMRI/MRSI examination at MSKCC if placed on deferred therapy protocol
  6. In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six months of eMRI/MRSI study

Exclusion Criteria:

  1. Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery)
  2. Inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status
  3. Presence of known contraindication to eMRI
  4. Unwillingness or inability to undergo placement of endorectal MR coil or ultrasound probe. As is the case for a standard MR exam, the presence of a pacemaker or aneurysm clips could pose a risk to patients, making them unable to have an eMRI, and therefore unable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eMRI/MRSI
Patients will undergo eMRI/MRSI examination. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position.
Other: eMRI/MRSI
Patients will undergo eMRI/MRSI examination. All subjects will be asked to administer a Fleet enema on the day of the study in order to reduce the potential for fecal residue to interfere with imaging acquisition and quality. Upon arrival at the MRI suite, patients will be asked to complete a standard MRI screening form. Patients will be scanned in the supine position. The entire eMRI/MRSI study will be performed within 55-60 minutes.
Other Names:
  • All patients enrolled in the protocol will have clinically indolent disease as
  • defined by NCCN guidelines. Treatment selection between definitive treatment
  • and deferred therapy will be decided jointly by the patient and the treating
  • physician (non-randomized selection). Patients will be treated with radical
  • prostatectomy (RP) or radiation therapy (RT) or will be placed on deferred
  • therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In a population of patients designated as clinically indolent by NCCN guidelines, we will evaluate the ability of eMRI/MRSI to predict pathologically indolent cancer. eMRI/MRSI findings will be compared with step-section pathology.
Time Frame: October 2010
October 2010

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In the patients who are identified as harboring indolent prostate cancer by both clinical guidelines and eMRI/MRSI, clinical progression of disease will be evaluated in a cohort of patients receiving deferred therapy.
Time Frame: October 2010
October 2010
We will explore whether eMRI/MRSI markers of progression correlate with clinical markers of progression.
Time Frame: October 2010
Patients undergoing deferred treatment will undergo followup eMRI/MRSI exams before surveillance biopsies, beginning approximately 12-18 months after confirmatory biopsy.
October 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Hedvig Hricak, M.D., Ph.D, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 28, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2011

Last Update Submitted That Met QC Criteria

October 14, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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