NCT03122470

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

Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-05-20
• Completion: 2023-06-20
• First posted: 2017-04-20
• Last updated: 2023-03-16

Regulatory

• FDA-regulated device study