Prostate Cancer

EA8171



Testing Whether A Novel MRI Imaging Approach Will Find Aggressive Disease before Surgery, which May Help Physicians Decide the Best Treatment Plan for Patients with Newly Diagnosed Prostate Cancer

STATUS: Active


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.
  • Men, age >= 18 years, diagnosed within 120 days prior to registration with prostate cancer for whom definitive surgical treatment is indicated * Note: Patients previously diagnosed with prostate cancer for which surgery is not indicated may be enrolled if they undergo a repeat biopsy (within 120 days prior to registration and for reasons including, but not limited to, discordant biopsy results) that indicates definitive treatment with surgery

  • Confirmation of payment, insurance pre-authorization, or Medicare for mpMRI

  • Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)

  • Prior surgical and/or non-surgical treatment for prostate cancer

  • Prior hip replacement or other major pelvic surgery

  • Unable to obtain confirmation of payment, insurance pre-authorization, or Medicare for mpMRI

United States
AZ
Phoenix
Mayo Clinic Hospital in Arizona
Status: ACTIVE
Contact: Site Public Contact

Scottsdale
Mayo Clinic in Arizona
Status: ACTIVE
Contact: Site Public Contact

CT
New Haven
Yale University
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswers@yale.edu

FL
Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact

University of Florida Health Science Center - Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Email: trials@cancer.ufl.edu

HI
Aiea
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact

Straub Pearlridge Clinic
Status: ACTIVE
Contact: Site Public Contact

Honolulu
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact

Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact

IA
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

IL
Zion
Midwestern Regional Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

IN
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: iutrials@iu.edu

KS
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Overland Park
University of Kansas Hospital-Indian Creek Campus
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

LA
Metairie
East Jefferson General Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

LSU Healthcare Network / Metairie Multi-Specialty Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

MA
Boston
Brigham and Women's Hospital
Status: ACTIVE
Contact: Site Public Contact

MI
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

Grand Rapids
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: CTOResearch@hfhs.org

MN
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact

MO
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

Washington University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@siteman.wustl.edu

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

NH
Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NY
New York
NYP / Weill Cornell Medical Center
Status: ACTIVE
Contact: Site Public Contact

Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact

OR
Medford
Rogue Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@asante.org

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Thomas Jefferson University Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: ONCTrialNow@jefferson.edu

University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact

TN
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact

TX
Conroe
MD Anderson in The Woodlands
Status: ACTIVE
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

MD Anderson West Houston
Status: ACTIVE
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

League City
MD Anderson League City
Status: ACTIVE
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

San Antonio
Audie L Murphy VA Hospital
Status: ACTIVE
Contact: Site Public Contact

University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

Sugar Land
MD Anderson in Sugar Land
Status: ACTIVE
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

WI
Waukesha
ProHealth Waukesha Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org

WV
Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

PRIMARY OBJECTIVES:
I. To estimate the diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score based on local site imaging review of multiparametric (mp)MRI (T2 weighted [2W], diffusion weighted imaging [DWI] and dynamic contrast-enhanced [DCE]) to detect clinically significant 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 clinically significant prostate cancer.

SECONDARY OBJECTIVE:
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.

EXPLORATORY OBJECTIVE:
I. All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.

EXPLORATORY TOBACCO USE OBJECTIVES:
I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic]) and dose modifications.
II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.
III. To examine quitting behaviors and behavioral counseling/ support and cessation medication utilization.
IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE:
Patients undergo mpMRI within 3 months prior to scheduled surgery.

After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


EA8171 Home Page
ECOG-ACRIN Cancer Research Group