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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: MRI guided biopsy Procedure: TRUS biopsy||Not Applicable|
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:
- To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
- To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
- To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
- To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.
- 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.
- To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
- To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||162 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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
- 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.
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
|Contact: Vikas Gulani, MD, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Vikas Gulani, MD, PhD||University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center|