Diagnostic Yield and Early Outcomes of Radical Prostatectomy Without Prior Histopathologic Diagnosis: A Single-Arm Systematic Review and Meta-analysis

<title>Abstract</title> <p>Purpose To evaluate the pathological, oncological, and functional outcomes of radical prostatectomy (RP) performed without prior histopathologic confirmation of prostate cancer in patients with a high clinical suspicion of clinically significant prostate cancer (csPCa). Methods We systematically searched PubMed, Embase, Google Scholar, and Cochrane databases for studies evaluating biopsy-free RP. Adult men with a high clinical suspicion of csPCa based on multiparametric MRI and/or PSMA-PET with elevated PSA or PSA density were included. A single-arm random-effects meta-analysis was performed to estimate the pooled proportions of csPCa, benign pathology, overtreatment, and positive surgical margins (PSM). Results Eleven studies comprising 648 patients were included, csPCa was identified in 94.2% of patients (95% CI, 88.4–97.2), whereas benign pathology occurred in only 0.3%. The pooled overtreatment rate was 5.7%, and PSM was observed in 25.4% of cases. Study-level subgroup analysis suggested a higher diagnostic yield in biopsy-naïve cohorts than in cohorts including patients with a previous negative biopsy (95% vs. 80%; p = 0.005), with no significant differences according to imaging modality or surgical approach. Functional outcomes suggested favorable early urinary continence and erectile function recovery; however, heterogeneous and incomplete reporting precluded quantitative synthesis, and these findings were based on descriptive data only. Overall risk of bias was serious, primarily because of verification bias arising from participant selection. Conclusions Biopsy-free RP is a promising imaging-driven strategy for highly selected patients with a high probability of csPCa, achieving a high pathological yield of clinically significant disease with a very low observed rate of benign surgery. However, the observed PSM rate of 25.4%, whose interpretation is limited by the absence of a comparator arm, together with the limited, predominantly retrospective evidence, precludes routine clinical adoption.</p>