Objective: To compare the efficiency of contrast-enhanced colour Doppler ultrasound (CECD-US) targeted biopsy versus systematic biopsy (SB) for PCa detection in 1,776 men.
Methods: Retrospective, single-centre, diagnostic accuracy study from 2002 until 2006 in 1,776 male volunteers with a serum total PSA of 1.25 ng/ml or greater. In each patient five CECD-US targeted biopsies were performed in hypervascular areas in the peripheral zone during intravenous injection of a second-generation microbubble US contrast agent. Subsequently, another examiner performed ten SBs. The PCa detection rates for the two techniques were compared.
Results: Of 1,776 patients, cancer was detected in 559 patients (31%), including 476 of the 1,776 patients (27%) with CECD-US and 410 (23%) with SB (p < 0.001). The detection rate for CECD-US targeted biopsy cores (10.8% or 961 of 8,880 cores) was significantly better than for SB cores (5.1% or 910 of 17,760 cores, p < 0.001). Among patients with a positive biopsy for PCa, cancer was detected by CECD-US alone in 149 patients (27%) and by SB alone in 83 (15%) (p < 0.001).
Conclusion: This study represents the largest clinical trial to date, demonstrating a significant benefit of CECD-US targeted biopsy relative to SB.