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Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03122470
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : May 3, 2019
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE April 17, 2017
First Posted Date  ICMJE April 20, 2017
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE August 1, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • Number of patients with the most likely diagnosis based on the five-point scale - PIRADS [ Time Frame: Up to two weeks after MRI ]
    Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
  • Number of patients with true diagnosis based on biopsy pathology [ Time Frame: Up to two weeks after MRI ]
    1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03122470 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • biopsy and MRI based diagnosis match in at least 8/10 patients [ Time Frame: Up to two weeks after MRI ]
    The score based on the true diagnosis and most likely diagnosis as agreed on by classifiers is the same in at least 80% of patients
  • Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy [ Time Frame: Up to two weeks after MRI ]
    The diagnostic performance of MRI guided biopsy techniques will be compared with standard TRUS biopsy using a single sample of patients undergoing both biopsy techniques. It has been reported that MRI consistently detects a larger number of clinically significant prostate cancers (sensitivity - 0.91 for MRI-guided biopsy vs 0.76 for TRUS biopsy), while avoiding the detection of cancers that are clinically insignificant, as compared to TRUS biopsy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer
Official Title  ICMJE Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
Brief Summary MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
Detailed Description

The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:

  1. To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
  2. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
  3. To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
  4. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.

Secondary Objectives:

  1. To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
  2. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
  3. To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Device: MRI guided biopsy
    The MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team.
    Other Names:
    • Prostate MRI
    • Pelvic MRI
  • Procedure: TRUS biopsy
    The TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings.
    Other Name: Prostate Biopsy
Study Arms  ICMJE Experimental: MRI guided biopsy + TRUS biopsy
Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer
  • Device: MRI guided biopsy
  • Procedure: TRUS biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer

Inclusion criteria for sub-group follow-up scans:

1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

Exclusion Criteria:

  • Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
  • The presence of an implanted pacemaker or implanted defibrillator device.
  • Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
  • Implanted medical device not described above that is not MRI-compatible;
  • Known history of severe claustrophobia;
  • For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) < 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
  • Minors will be excluded.
  • Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vikas Gulani, MD, PhD 216-844-3112
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03122470
Other Study ID Numbers  ICMJE CASE10815
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vikas Gulani, MD, PhD University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP