Back to resultsMRI/MRSI in Risk Assessment of Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eMRI/MRSI
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate
Eligibility 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 surveillance TRUS-guided prostate biopsies 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.
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eMRI/MRSI
Arm Description
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.
Outcomes
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.
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.
We will explore whether eMRI/MRSI markers of progression correlate with clinical markers of progression.
Patients undergoing deferred treatment will undergo followup eMRI/MRSI exams before surveillance biopsies, beginning approximately 12-18 months after confirmatory biopsy.
Full Information
NCT ID
NCT00582543
First Posted
December 21, 2007
Last Updated
October 14, 2011
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00582543
Brief Title
MRI/MRSI in Risk Assessment of Prostate Cancer Patients
Official Title
MRI/MRSI in Risk Assessment of Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
4. Oversight
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Prostate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
357 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eMRI/MRSI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
eMRI/MRSI
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
We will explore whether eMRI/MRSI markers of progression correlate with clinical markers of progression.
Description
Patients undergoing deferred treatment will undergo followup eMRI/MRSI exams before surveillance biopsies, beginning approximately 12-18 months after confirmatory biopsy.
Time Frame
October 2010
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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 surveillance TRUS-guided prostate biopsies 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedvig Hricak, M.D., Ph.D
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center website
Learn more about this trial
MRI/MRSI in Risk Assessment of Prostate Cancer Patients
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