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MRI/MRSI in Risk Assessment of Prostate Cancer Patients

This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, October 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582543
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: eMRI/MRSI

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Sodium phosphate, dibasic    Pramocaine    Pramoxine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Open Label, Single Group Assignment, Efficacy Study
Official Title:   MRI/MRSI in Risk Assessment of Prostate Cancer Patients

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:   1005
Study Start Date:   October 2005
Estimated Study Completion Date:   October 2010
Estimated Primary Completion Date:   October 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
eMRI/MRSI: Experimental
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.

Detailed Description:

In this study, patients identified in the clinic as likely to have low-risk, organ-confined prostate cancer 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

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

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 (at 6, 18 and 36 months) TRUS-guided prostate biopsy 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582543

Contacts
Contact: Hedvig Hricak, M.D., Ph.D.     hricakh@mskcc.org    

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center     Recruiting
      New York, New York, United States, 10065
      Contact: Hedvig Hricak, M.D., Ph.D.         hricakh@mskcc.org    

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)

Investigators
Principal Investigator:     Hedvig Hricak, M.D., Ph.D     Memorial Sloan-Kettering Cancer Center    
  More Information


Memorial Sloan-Kettering Cancer Center website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Hedvig Hricak, MD, PhD )
Study ID Numbers:   05-113, NIH # CA76423
First Received:   December 21, 2007
Last Updated:   October 1, 2008
ClinicalTrials.gov Identifier:   NCT00582543
Health Authority:   United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate Cancer  
Prostate  

Study placed in the following topic categories:
Sodium phosphate
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 31, 2008




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