MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 12/23/2017 |
| Start Date: | September 10, 2014 |
| End Date: | December 8, 2017 |
Novel Screening MRI for the Detection of Prostate Cancer
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.
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.
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.
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)
We found this trial at
1
site
11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Principal Investigator: Robert Abouassaly
Phone: 216-844-4831
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