MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02131207|
Recruitment Status : Terminated (Principal Investigator Left Institution)
First Posted : May 6, 2014
Last Update Posted : December 21, 2017
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Device: magnetic resonance imaging Procedure: prostate biopsy|
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%).
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.
Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.
|Study Type :||Observational|
|Actual Enrollment :||139 participants|
|Official Title:||Novel Screening MRI for the Detection of Prostate Cancer|
|Actual Study Start Date :||September 10, 2014|
|Actual Primary Completion Date :||December 8, 2017|
|Actual Study Completion Date :||December 8, 2017|
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
Procedure: prostate biopsy
Undergo prostate biopsy
- Increased detection of clinically significant prostate cancer [ Time Frame: 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%
- Detection of clinically significant prostate cancer using 3D T2 SPACE [ Time Frame: 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 [ Time Frame: Up to 1 year ]Number of patients with positive prostate cancer detection using 3D T2 HASTE
- Pathology specimen correlation with MRI findings [ Time Frame: Up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131207
|United States, Ohio|
|University Hospitals, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Robert Abouassaly||Case Comprehensive Cancer Center|