Early versus delayed laparoscopic radical prostatectomy following transperineal biopsy: a randomized clinical trial

Objective: to assess whether shortening the time interval between transperineal prostate biopsy and laparoscopic radical prostatectomy (lRP) affects postoperative complications and early pathological outcomes.

Material and Methods. Prospective single-center randomized trial included 28 men with localized prostate cancer. Patients were assigned to two treatment groups: early lRP (n=9) performed 9–23 days after biopsy (median 14 days) and delayed lRP (n=19) performed 51–180 days after biopsy (median 105 days). The primary endpoint was complication-free survival (time from surgery to the first postoperative complication). Kaplan–Meier analysis (log-rank), Cox regression and exploratory prediction models were used.

Results. No statistically significant differences in baseline characteristics (age, BMi, PSA, prostate volume, comorbidities) between the treatment groups were found (p>0.05). Operative time was shorter in the early lRP group than in the delayed lRP (110 (85–230) min vs 145 (90–265) min, p=0.017), while blood loss was similar (150 (50–500) ml vs 150 (100–600) ml, p=0.37). Complications within 30 days occurred in 2 (22.2 %) vs 3 (15.8 %) (p=1.0); all events occurred on postoperative days 6–9 and none beyond day 30. Thirty-day complication-free survival was 77.8 % vs 84.2 % with no significant difference (log-rank p=0.648); Cox HR for immediate surgery was 1.50 (95 % Ci 0.25–8.96).

Conclusion. in this small randomized cohort, early lRP after transperineal biopsy showed no increase in complication rates and negative impact on pathological outcomes compared to delayed lRP. larger studies are required to confirm equivalence margins and evaluate long-term oncologic and functional outcomes.

1. Siegel R.L., Giaquinto A.N., Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; 74(1): 12–49. doi: 10.3322/caac.21820. Erratum in: CA Cancer J Clin. 2024; 74(2): 203. doi: 10.3322/caac.21830.

2. Freedland S.J., Nair S., Lin X., Karsh L., Pieczonka C., Potluri R., Brookman-May S.D., Mundle S.D., Fleming S., Agarwal N. A US realworld study of treatment patterns and outcomes in localized or locally advanced prostate cancer patients. World J Urol. 2023; 41(12): 3535–42. doi: 10.1007/s00345-023-04680-w.

3. Wenzel M., Theissen L., Preisser F., Lauer B., Wittler C., Humke C., Bodelle B., Ilievski V., Kempf V.A.J., Kluth L.A., Chun F.K.H., Mandel P., Becker A. Complication Rates After TRUS Guided Transrectal Systematic and MRI-Targeted Prostate Biopsies in a High-Risk Region for Antibiotic Resistances. Front Surg. 2020; 7: 7. doi: 10.3389/fsurg.2020.00007.

4. Hu J.C., Assel M., Allaf M.E., Vickers A.J., Ehdaie B., Cohen A.J., Green D.A., Ghazi A., Ristau B.T., Kowalczyk K.J., George A.K., Patel H.D., Montgomery J.S., Han M., Rezaee M., Pavlovich C.P., Patel N.A., Ross A.E., Kundu S.D., Wang G.J., Shoag J.E., Singla N., Stensland K., Gorin M.A., Schaeffer A.J., Schaeffer E.M. Transperineal vs Transrectal Prostate Biopsy-The PREVENT Randomized Clinical Trial. JAMA Oncol. 2024; 10(11): 1590–93. doi: 10.1001/jamaoncol.2024.4000.

5. Stangl F.P., Day E., Vallée M., Bilsen M.P., Grossmann N.C., Falkensammer E., Tapia-Herrero A.M., Pilatz A., Wagenlehner F., Tandogdu Z., Bjerklund Johansen T.E., Gross T., Medina-Polo J., Marschall J., Lusuardi L., Bonkat G., Köves B., Schneidewind L., Kranz J. Infectious Complications After Transrectal Versus Transperineal Prostate Biopsy: A Systematic Review and Meta-analysis. Eur Urol Focus. 2026; 12(2): 275–83. doi: 10.1016/j.euf.2025.07.005.

6. Xiang J., Yan H., Li J., Wang X., Chen H., Zheng X. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: a systematic review and meta-analysis. World J Surg Oncol. 2019; 17(1): 31. doi: 10.1186/s12957-019-1573-0.

7. Lai C.M., Wu R.C., Wu C.H., Wang C.T., Lin V.C. Does the Timing of Performing Robot-assisted Radical Prostatectomy after Prostate Biopsy Affect the Outcome? Urol Sci. 2022. 33(2): 63–69. doi: 10.4103/UROS.UROS_39_21.

8. Westerman M.E., Sharma V., Bailey G.C., Boorjian S.A., Frank I., Gettman M.T., Thompson R.H., Tollefson M.K., Karnes R.J. Impact of time from biopsy to surgery on complications, functional and oncologic outcomes following radical prostatectomy. Int Braz J Urol. 2019; 45(3): 468–77. doi: 10.1590/S1677-5538.IBJU.2018.0196.

9. European Association of Urology. Prostate Cancer: EAU Guidelines. 2024. [Internet]. [cited 27.02.2026]. URL: https://uroweb.org/guidelines/prostate-cancer.

10. Brown R., Beyer B., Knipper S., Mehring G., Budäus L., Tennstedt P., Graefen M., Pose R.M. Impact of the time interval between biopsy and radical prostatectomy on functional outcomes. World J Urol. 2024; 42(1): 640. doi: 10.1007/s00345-024-05324-3.

11. Xia L., Talwar R., Chelluri R.R., Guzzo T.J., Lee D.J. Surgical Delay and Pathological Outcomes for Clinically Localized High-Risk Prostate Cancer. JAMA Netw Open. 2020; 3(12): e2028320. doi: 10.1001/jamanetworkopen.2020.28320.

12. Ginsburg K.B., Curtis G.L., Timar R.E., George A.K., Cher M.L. Delayed Radical Prostatectomy is Not Associated with Adverse Oncologic Outcomes: Implications for Men Experiencing Surgical Delay Due to the COVID-19 Pandemic. J Urol. 2020; 204(4): 720–25. doi: 10.1097/JU.0000000000001089.

13. Hikita K., Honda M., Shimizu R., Teraoka S., Kimura Y., Yumioka T., Tsounapi P., Iwamoto H., Morizane S., Takenaka A. Influence of the time interval between biopsy and surgery on the biochemical recurrence after robot-assisted radical prostatectomy in Japanese patients. Asian J Surg. 2022; 45(11): 2179–84. doi: 10.1016/j.asjsur.2021.10.022.

14. Li J., Jiang Q., Li Q., Zhang Y., Gao L. Does time interval between prostate biopsy and surgery affect outcomes of radical prostatectomy? A systematic review and meta-analysis. Int Urol Nephrol. 2020; 52(4): 619–31. doi: 10.1007/s11255-019-02344-6.

15. Kim S.J., Ryu J.H., Yang S.O., Lee J.K., Jung T.Y., Kim Y.B. Does the Time Interval from Biopsy to Radical Prostatectomy Affect the Postoperative Oncologic Outcomes in Korean Men? J Korean Med Sci. 2019; 34(37): e234. doi: 10.3346/jkms.2019.34.e234.

16. Schulz K.F., Altman D.G., Moher D.; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010; 8: 18. doi: 10.1186/1741-7015-8-18.

17. Collins G.S., Reitsma J.B., Altman D.G., Moons K.G. Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD): the TRIPOD statement. Ann Intern Med. 2015; 162(1): 55–63. doi: 10.7326/M14-0697.

18. Dindo D., Demartines N., Clavien P.A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2): 205–13. doi: 10.1097/01. sla.0000133083.54934.ae.

19. Kaplan E.L., Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958; 53(282): 457–81. doi: 10.2307/2281868.

20. Cox D.R. Regression models and life-tables. J R Stat Soc Series B Stat Methodol. 1972; 34(2): 187–220.

21. Gupta N., Bivalacqua T.J., Han M., Gorin M.A., Challacombe B.J., Partin A.W., Mamawala M.K. Evaluating the impact of length of time from diagnosis to surgery in patients with unfavourable intermediaterisk to very-high-risk clinically localised prostate cancer. BJU Int. 2019; 124(2): 268–274. doi: 10.1111/bju.14659.

22. Patel P., Sun R., Shiff B., Trpkov K., Gotto G.T. The effect of time from biopsy to radical prostatectomy on adverse pathologic outcomes. Res Rep Urol. 2019; 11: 53–60. doi: 10.2147/RRU.S187950.

23. Engl T., Mandel P., Hoeh B., Preisser F., Wenzel M., Humke C., Welte M., Köllermann J., Wild P., Deuker M., Kluth L.A., Roos F.C., Chun F.K.H., Becker A. Impact of “Time-From-Biopsy-to-Prostatectomy” on Adverse Oncological Results in Patients With Intermediate and High-Risk Prostate Cancer. Front Surg. 2020; 7: 561853. doi: 10.3389/fsurg.2020.561853.

24. Lee M.C., Erickson T.R., Stock S., Howard L.E., De Hoedt A.M., Amling C.L., Aronson W.J., Cooperberg M.R., Kane C.J., Terris M.K., Klaassen Z., Freedland S.J., Wallis C.J.D. Association between delay to radical prostatectomy and clinically meaningful outcomes among patients with intermediate and high-risk localized prostate cancer. J Urol. 2022; 207(3): 592–600. doi: 10.1097/JU.0000000000002304.

25. Nguyen D.D., Haeuser L., Paciotti M., Reitblat C., Cellini J., Lipsitz S.R., Kibel A.S., Choudhury A.D., Cone E.B., Trinh Q.D. Systematic Review of Time to Definitive Treatment for Intermediate Risk and High Risk Prostate Cancer: Are Delays Associated with Worse Outcomes? J Urol. 2021; 205(5): 1263–74. doi: 10.1097/JU.0000000000001601.

26. Laukhtina E., Sari Motlagh R., Mori K., Quhal F., Schuettfort V.M., Mostafaei H., Katayama S., Grossmann N.C., Ploussard G., Karakiewicz P.I., Briganti A., Abufaraj M., Enikeev D., Pradere B., Shariat S.F. Oncologic impact of delaying radical prostatectomy in men with intermediateand high-risk prostate cancer: a systematic review. World J Urol. 2021; 39(11): 4085–99. doi: 10.1007/s00345-021-03703-8.

27. Chan V.W., Tan W.S., Asif A., Ng A., Gbolahan O., Dinneen E., To W., Kadhim H., Premchand M., Burton O., Koe J.S., Wang N., Leow J.J., Giannarini G., Vasdev N., Shariat S.F., Enikeev D., Ng C.F., Teoh J.Y. Effects of Delayed Radical Prostatectomy and Active Surveillance on Localised Prostate Cancer-A Systematic Review and Meta-Analysis. Cancers (Basel). 2021; 13(13): 3274. doi: 10.3390/cancers13133274.