Rationale and protocol for randomized study of transrectal and transperineal prostate biopsy efficacy and complications (ProBE-PC study)

Background Rrisk of infection and hospitalization after transrectal prostate biopsy (TRBx) has been increasing worldwide. Several modified antibiotic regimens have met with variable success in preventing such infections. Transperineal prostate biopsy (TPBx) is increasingly recommended as the preferred alternative due to a potentially lower risk of post-biopsy infections. Aim of this review is to define the magnitude of post-biopsy complications and the effectiveness of preventive strategies, including TPBx approach. Methods We performed a focused review of literature on infectious complications after TRBx and detailed the use of various preventive measures. We summarized the effectiveness of several preventive measures, including TPBx, and outlined the inconsistencies in reported outcomes. We identified potential barriers to the uptake of TPBx, including the gap in knowledge such as lack of high-quality evidence. Results Several antibiotic prophylaxis protocols, including targeted and augmented, have been utilized for TRBx without demonstrating a clearly superior regimen. Of the non-antibiotic preventive measure, povidone-iodine rectal prep appears to be most effective strategy. Several single-arm cohort studies have reported very low rates of infections after TPBx and demonstrated the feasibility of an office-based procedure. However, barriers to the adoption of TPBx exist including retrospective data, and conflicting results showing minimal reduction in complications with increased burden of resource utilization. Presently, there are no randomized studies comparing the infectious complications after TRBx and TPBx. We discuss the rationale and protocol for a randomized controlled trial to determine the comparative effectiveness of biopsy techniques. Conclusions TPBx approach has the potential to lower the rate of post-biopsy infections and hospitalizations. However, there are several barriers to widespread adoption of this approach including inconsistencies in reported outcomes and lack of Level-1 evidence. Randomized controlled studies are required to directly compare the infectious complications associated with each biopsy procedure.