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

NCT ID: NCT03122470

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-06-20

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MRI guided biopsy

Intervention Type: DEVICE

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.

TRUS biopsy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Prostate MRI; Pelvic MRI; Prostate Biopsy

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee Ponsky, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Other Identifiers

CASE10815

Identifier Type: -

Identifier Source: org_study_id