MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

NCT02131207 | Terminated FDA Device

• 3 other identifiers: CASE6813NCI-2014-00822P30CA043703
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Increased detection of clinically significant prostate cancer

  Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%

  Up to 1 year

Secondary Outcomes (2)

• Detection of clinically significant prostate cancer using 3D T2 SPACE

  Up to 1 year

• Detection of clinically significant prostate cancer using 3D T2 HASTE

  Up to 1 year

Other Outcomes (1)

• Pathology specimen correlation with MRI findings

  Up to 1 year

Study Arms (1)

Diagnostic (MRI and biopsy)

Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy.

Device: magnetic resonance imaging; Procedure: prostate biopsy

Interventions

magnetic resonance imaging DEVICE

Undergo pelvic MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Diagnostic (MRI and biopsy)

prostate biopsy PROCEDURE

Undergo prostate biopsy

Also known as: biopsy of prostate, prostatic biopsy

Diagnostic (MRI and biopsy)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam

You may qualify if:

• Abnormal prostate-specific antigen (PSA) blood test
• \> 2.5 ng/mL for men \< 50 years (yrs) of age
• \> 3.5 ng/mL for men \< 60 yrs of age
• \> 4.5 ng/mL for men \< 70 yrs of age
• Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
• Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer

You may not qualify if:

• Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
• Contraindications to TRUS/prostate biopsy (BX)
• Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder
• Active urinary tract infection
• Acute painful perianal disorder (i.e. rectal abscess)
• Contraindications to MRI
• 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 claustrophobia
• Individuals with a short life expectancy (\< 10 years)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University Hospitals, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Robert Abouassaly

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: May 6, 2014
• Study Start: September 10, 2014
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: December 21, 2017

Record last verified: 2017-12

Locations

US (1)