Prostate Cancer Clinical Trial
ARFI Imaging for Targeted Prostate Biopsy
Summary
The purpose of this study is to evaluate a new ultrasound technique. This technique may provide additional and improved information about the stiffness and sizes of the internal structures of your prostate in order to improve the guidance for a targeted biopsy. The investigational, custom-designed probe and needle guide will be used to produce images of your prostate and provide guidance for up to 4 additional biopsy samples (cores) prior to a standard magnetic resonance (MR) ultrasound fusion biopsy procedure. Above the time required for the MR ultrasound fusion biopsy, this study will take up to 30 additional minutes of time for collection of the investigational device guided collection of biopsy samples Risks of participation include increased time under anesthesia (to collect additional biopsies) and slight heating of tissue.
Eligibility Criteria
Inclusion Criteria:
Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;
Men who are willing to participate in the study;
Subjects must freely sign informed consent to enroll in the study;
Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.
18 years or older
Exclusion Criteria:
Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;
Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);
standard pharmacological treatment of BPH is allowable
Men who are mentally impaired and cannot give written consent;
Men with anomalies of the rectum.
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There is 1 Location for this study
Durham North Carolina, 27705, United States More Info
Principal Investigator
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