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

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ClinicalTrials.gov Identifier: NCT03122470
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: MRI guided biopsy Procedure: TRUS biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122470


Contacts
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Contact: Vikas Gulani, MD, PhD 216-844-3112 vxg46@case.edu

Locations
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United States, Ohio
University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Vikas Gulani, MD, PhD    216-844-3112    vxg46@case.edu   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Vikas Gulani, MD, PhD University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03122470     History of Changes
Other Study ID Numbers: CASE10815
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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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
Keywords provided by Case Comprehensive Cancer Center:
TRUS biopsy
Pelvic MRI
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases