MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Terminated

• Conditions: Prostate Cancer
• Interventions: Device: magnetic resonance imaging; Procedure: prostate biopsy

• Registration Number: NCT02131207
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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 Timeline

• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-06
• Study Start: 2014-09-10
• Status Verified: 2017-12
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 139

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Increased detection of clinically significant prostate cancer	Up to 1 year	Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%

Secondary Outcome Measures

Name	Time	Method
Detection of clinically significant prostate cancer using 3D T2 SPACE	Up to 1 year	Number of patients with positive prostate cancer detection using 3D T2 SPACE
Detection of clinically significant prostate cancer using 3D T2 HASTE	Up to 1 year	Number of patients with positive prostate cancer detection using 3D T2 HASTE

Trial Locations

Locations (1)

University Hospitals, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States