MRI/MRSI in Risk Assessment of Prostate Cancer Patients - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

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 ]
Patients undergoing deferred treatment will undergo followup eMRI/MRSI at 6, 18, and 36 months after the initial study. We will explore whether eMRI/MRSI markers of progression correlate with clinical markers of progression. [ 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.

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 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

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Gleason ≤6 (grade 3 + 3 or lower) biopsy proven prostate cancer
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)
No evidence of disseminated disease (bone or lymph node metastases)
Treatment—radical prostatectomy, radiation therapy, or deferred therapy—will be at MSKCC
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
In the surgical cohort, RP (radical prostatectomy) is scheduled to occur within six months of eMRI/MRSI study

Exclusion Criteria:

Prior treatment (e.g. with hormonal therapy, radical prostatectomy, radiation therapy or cryosurgery)
Inability to give informed consent because of age, general medical or psychiatric condition, or physiologic status
Presence of known contraindication to eMRI
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

Additional Information:

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

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Hedvig Hricak, MD, PhD )
Study ID Numbers:	05-113, NIH # CA76423
Study First Received:	December 21, 2007
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00582543 History of Changes
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
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009