A PROSPECTIVE RANDOMIZED TRIAL COMPARING CONTRAST-ENHANCED TARGETED VERSUS SYSTEMATIC ULTRASOUND GUIDED BIOPSIES: IMPACT ON PROSTATE CANCER DETECTION

Purpose: We performed a prospective randomized trial comparing less than or equal to 5 contrast-enhanced colour Doppler ultrasound targeted biopsy cores to 10 grey-scale ultrasound guided systematic biopsy cores to determine the impact on the cancer detection rate.

Methods and Materials: We prospectively randomized 100 PSA screening volunteers with an elevated PSA (>1.25 ng/mL and free-to-total PSA <18%) to undergo contrast-enhanced targeted or systematic biopsy. Contrast-enhanced targeted biopsies with a limited number of cores (<6) were performed of hypervascular areas of the peripheral zone 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 colour signal, 1=low density, 2=medium density, and 3 high density of colour signals. The transit-time after bolus administration of the US contrast-agent was assessed. Ten systematic biopsies 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 systematic biopsy. The cancer detection rate was significantly better for the targeted approach (p<0.04). The detection rate for targeted biopsy cores (15.6% or 39/250 cores) was significantly better than for systematic biopsy cores (6.8% or 34/500 cores, p<0.001). Assessment of the transit-time demonstrated an earlier and higher peak enhancement of cancer compared with benign tissue.

Conclusions: The overall cancer detection rate is significantly increased by contrast-enhanced colour Doppler targeted biopsy compared with systematic biopsy.