Robot-Assisted Radical Prostatectomy in PIRADS 5 Lesions Without Prior Biopsy: Is Biopsy Really Necessary in This Cohort?

Introduction: Conventionally, confirmation of clinically significant prostate cancer (csPCa) (Gleason grade group ≥ 2) involves an initial multiparametric magnetic resonance imaging (mpMRI) followed by biopsy. Prostate biopsy incurs inherent risks of infection, bleeding, patient discomfort, and a 6-week delay before robot-assisted laparoscopic radical prostatectomy (RALP). We explored the feasibility of immediate RALP in men with PIRADS 5 lesions without preceding biopsy. Methodology: After obtaining institutional review board approval, a prospective analysis was conducted on 235 patients with PIRADS 5 lesions on mpMRI from December 2018 to February 2023. Patients were divided into 2 groups as follows: Group NoBiopsy (biopsy not done before RALP, cases, n = 118) and Group YesBiopsy (biopsy done before RALP, controls, n = 117). Baseline preoperative, intraoperative, and postoperative parameters were analyzed. Functional outcomes were monitored at 1, 3-, 6-, 9-, and 12-months follow-up post-RALP. Statistical analysis was performed using SPSS and STATA. Results: Ninety-five percent of cases and 87.17% controls had csPCa on final pathology post-RALP. Multivariable analysis did not find significant association between biopsy status and csPCa. Abnormal digital rectal examination (DRE), family history, preoperative PSA, and MRI lesion volume predicted csPCa. Significant differences were observed in console time (NoBiopsy vs. YesBiopsy, 60 ± 10 vs. 70 ± 9 minutes, p < 0.001) and estimated blood loss (80 ± 20 vs. 100 ± 30 mL, p < 0.01) between groups. At 6 months post-RALP, 96% of men in Group NoBiopsy were continent, compared with 88% of men in Group YesBiopsy (p < 0.04). All men in the study cohort were continent (0 pads) at 12 months post-RALP. Ninety-eight percent of cases and 92% of controls at 9 months and 12 months, respectively, were able to have penetrative sex with or without PDE-5 inhibitors post-RALP. Conclusion: RALP without antecedent prostate biopsy in men with PIRADS 5 lesions demonstrated substantial csPCa detection rates and superior functional outcomes, warranting further validation.