A prospective randomized trial comparing contrast-enhanced targeted versus systematic ultrasound guided biopsies: impact on prostate cancer detection.

Background: We performed a prospective randomized trial comparing 5 contrast-enhanced color Doppler (CECD) ultrasound (US) targeted biopsy cores to 10 gray-scale US guided systematic biopsy (SB) cores to determine the impact on the cancer detection rate.

Methods: We prospectively randomized 100 prostate specific antigen (PSA) screening volunteers with an elevated PSA (> or =1.25 ng/ml and free-to-total PSA < 18%) to undergo contrast-enhanced targeted or SB. Contrast-enhanced targeted biopsies with a limited number of five cores were performed into hypervascular areas of the peripheral zone (PZ) during administration of the US contrast agent SonoVue (Bracco, Italy). A subjective grading of the vascularity from 0 to 3 was used: grade 0, no color signal; 1, low density; 2, medium density; and 3, high density of color signals. Ten SBs were obtained in a standard spatial distribution. Cancer detection rates were compared in the groups.

Results: Cancer was detected in 16/50 subjects (32%) by targeted biopsy, and in 13/50 patients (26%) with SB. The cancer detection rate was significantly better for the targeted approach (P < 0.04, McNemar). The detection rate for targeted biopsy cores (15.6% or 39/250 cores) was significantly better than for SB cores (6.8% or 34/500 cores, P < 0.001, McNemar).

Conclusions: CECD targeted biopsy detected more cancers than SB with a reduced number of biopsy cores.