MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel Screening MRI for the Detection of Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: magnetic resonance imaging
* Procedure: prostate biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic (MRI and biopsy)<br>Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy. | Device: magnetic resonance imaging<br>* Undergo pelvic MRI<br>* Other names: nuclear magnetic resonance imaging;Procedure: prostate biopsy<br>* Undergo prostate biopsy<br>* Other names: prostatic biopsy;|

What is the study measuring?
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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 |