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.