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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01997 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EA8171 | Other Identifier | ECOG-ACRIN Cancer Research Group | |
| EA8171 | Other Identifier | CTEP | |
| U10CA180820 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
PRIMARY OBJECTIVES:
I. To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
I. To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.
TERTIARY OBJECTIVES:
I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.
OUTLINE:
Patients undergo mpMRI within 3 months prior to schedule surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (mpMRI) | Experimental | Patients undergo mpMRI within 3 months prior to schedule surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiparametric Magnetic Resonance Imaging | Diagnostic Test | Undergo mpMRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score | Will estimate the diagnostic performance as quantified by the area under the ROC curve. | Up to 2 years |
| Risk prediction model | To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score | Will estimate the diagnostic performance as quantified by the area under the ROC curve. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clare Tempany-Afdhal | ECOG-ACRIN Cancer Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | United States | ||
| Mayo Clinic in Arizona |
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| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| University of Florida Health Science Center - Jacksonville | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | United States |
| Queen's Medical Center | Honolulu | Hawaii | 96813 | United States |
| Straub Clinic and Hospital | Honolulu | Hawaii | 96813 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| Straub Pearlridge Clinic | ‘Aiea | Hawaii | 96701 | United States |
| Midwestern Regional Medical Center | Zion | Illinois | 60099 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic | Metairie | Louisiana | 70006 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Henry Ford West Bloomfield Hospital | West Bloomfield | Michigan | 48322 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| University of Pennsylvania/Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| MD Anderson in The Woodlands | Conroe | Texas | 77384 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| MD Anderson West Houston | Houston | Texas | 77079 | United States |
| MD Anderson League City | League City | Texas | 77573 | United States |
| Audie L Murphy VA Hospital | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| MD Anderson in Sugar Land | Sugar Land | Texas | 77478 | United States |
| West Virginia University Healthcare | Morgantown | West Virginia | 26506 | United States |
| ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | 53188 | United States |
| UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | 53188 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000081364 | Multiparametric Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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