NCT02131207

MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Novel Screening MRI for the Detection of Prostate Cancer

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DEVICE	magnetic resonance imaging	Undergo pelvic MRI
PROCEDURE	prostate biopsy	Undergo prostate biopsy

Timeline

• Start date: 2014-09-10
• Primary completion: 2017-12-08
• Completion: 2017-12-08
• First posted: 2014-05-06
• Last updated: 2017-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study