A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy

Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness. In this study, we aim to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

1. Age 18 years of age or older.
2. Serum PSA between 4 and 10 ng/mL.
3. A diagnosis of prostate cancer based on extended (twelve core) random prostate biopsy within three months prior to study entry.
4. Clinically localized prostate carcinoma i.e. TNM stage T2c or less.
5. The patient has elected to undergo radical prostatectomy to treat the prostate carcinoma.
6. The patient consents to undergo a diagnostic transrectal ultrasound of the prostate with elastography.

Exclusion Criteria:

1\. Any contraindication to transrectal ultrasonography, including prior anorectal surgery, inflammatory bowel disease, rectal fistula, or fissure-in-ano.