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

NCT03122470 | Withdrawn FDA Device

• 1 other identifier: CASE10815
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Keywords

TRUS biopsy; Pelvic MRI

Outcome Measures

Primary Outcomes (2)

• Number of patients with the most likely diagnosis based on the five-point scale - PIRADS

  Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant

  Up to two weeks after MRI

• Number of patients with true diagnosis based on biopsy pathology

  1\. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant

  Up to two weeks after MRI

Secondary Outcomes (2)

• biopsy and MRI based diagnosis match in at least 8/10 patients

  Up to two weeks after MRI

• Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy

  Up to two weeks after MRI

Study Arms (1)

MRI guided biopsy + TRUS biopsy

EXPERIMENTAL

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

Interventions

MRI guided biopsy 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.

Also known as: Prostate MRI, Pelvic MRI

MRI guided biopsy + TRUS biopsy

TRUS biopsy 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.

Also known as: Prostate Biopsy

MRI guided biopsy + TRUS biopsy

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer
• a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lee Ponsky, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: August 1, 2017
• Primary Completion: May 20, 2019
• Study Completion: June 20, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03