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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Institutes of Health (NIH) |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00582543 |
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 |
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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 |
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 |
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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.
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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.
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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
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hedvig Hricak, M.D., Ph.D. | hricakh@mskcc.org |
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 |
Principal Investigator: | Hedvig Hricak, M.D., Ph.D | Memorial Sloan-Kettering Cancer Center |
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: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00582543 |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Prostate |
Sodium phosphate Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |