MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
NCT ID: NCT02131207
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
139 participants
OBSERVATIONAL
2014-09-10
2017-12-08
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Diagnostic (MRI and biopsy)
Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy.
magnetic resonance imaging
Undergo pelvic MRI
prostate biopsy
Undergo prostate biopsy
Interventions
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magnetic resonance imaging
Undergo pelvic MRI
prostate biopsy
Undergo prostate biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \> 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
* 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)
40 Years
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Robert Abouassaly
Role: PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center
Locations
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University Hospitals, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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NCI-2014-00822
Identifier Type: REGISTRY
Identifier Source: secondary_id
CASE6813
Identifier Type: OTHER
Identifier Source: secondary_id
CASE6813
Identifier Type: -
Identifier Source: org_study_id