Prostate Carcinoma Clinical Trial
Official title:
Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.
PRIMARY OBJECTIVES:
I. To improve the treatment of patients with prostate cancer utilizing diagnostic
multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined
with molecular and clinical data to help determine the extent of prostate cancer and risk of
disease progression.
II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided
biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target
lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or
ultrasound-guided biopsy as the reference standard.
III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate
a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.
IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared
to transrectal ultrasound (TRUS)-guided systematic biopsy results.
OUTLINE:
Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric
endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal
MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric
endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care
approximately 2 weeks after transrectal MRI-guided biopsy.
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