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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00822 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE6813 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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Principal Investigator Left Institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (MRI and biopsy) | Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| magnetic resonance imaging | Device | Undergo pelvic MRI |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pathology specimen correlation with MRI findings | 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. | Up to 1 year |
Inclusion Criteria:
Abnormal prostate-specific antigen (PSA) blood test
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)
Contraindications to MRI
Individuals with a short life expectancy (< 10 years)
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This is a pilot study of patients from the University Hospitals urology clinics who have not previously been given a diagnosis of prostate cancer but who are awaiting a prostate biopsy due to an elevated PSA or abnormal digital rectal exam
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| Name | Affiliation | Role |
|---|---|---|
| Robert Abouassaly | Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| prostate biopsy | Procedure | Undergo prostate biopsy |
|
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Number of patients with positive prostate cancer detection using 3D T2 HASTE
| Up to 1 year |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |