MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Novel Screening MRI for the Detection of Prostate Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: magnetic resonance imaging; Procedure: prostate biopsy

Detailed Description

PRIMARY OBJECTIVES:

I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).

SECONDARY OBJECTIVES:

I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.

IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.

V. Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone.

OUTLINE:

Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.

• Study Type: Observational
• Enrollment (Actual): 139

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic (MRI and biopsy); Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy.	Device: magnetic resonance imaging; Undergo pelvic MRI; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging; Procedure: prostate biopsy; Undergo prostate biopsy; Other Names: biopsy of prostate; prostatic biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of clinically significant prostate cancer using 3D T2 SPACE	Number of patients with positive prostate cancer detection using 3D T2 SPACE	Up to 1 year
Detection of clinically significant prostate cancer using 3D T2 HASTE	Number of patients with positive prostate cancer detection using 3D T2 HASTE	Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathology specimen correlation with MRI findings	Statistical correlation of MRI findings with final pathology specimens in those patients who elect to be treated with radical prostatectomy for treatment of their biopsy detected prostate cancer with 0 showing no correlation and 1 showing perfect correlation between findings.	Up to 1 year

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Robert Abouassaly, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2014
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE6813 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00822 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No