Original Title: Transperineal sammenliknet med transrektal biopsitakning ved mistanke om prostatakreft: en fullstendig metodevurdering

Authors' objectives: We have summarized the efficacy and safety and performed a health economic evaluation of transperineal compared with transrectal biopsy in men with suspected prostate cancer or during follow-up after prostate cancer. We have also presented the results from recent systematic reviews that examined diagnostic accuracy of these two biopsy methods.

Authors' results and conclusions: For efficacy and safety, we included four randomized and one non-randomized study, as well as three registry studies: two large registry studies from England (Berry 2020, n = 73,630) and the United Kingdom (Tamhankar 2020, n = 486,467), and one from Japan. All the included studies used systematic biopsy. Tamhankar 2020 reported total results for the entire ten-year period (2008-2019), but also separately for the final twoyear period (2017-2019). Berry 2020 reported results for the period 2014-2017 and adjusted for biopsy time, age, ethnicity, comorbidity and low socio-economic status. These results are also included in Tamhankar 2020. The number of events was very small in the randomized and non-randomized studies. We, therefore, primarily emphasize the results from Tamhankar for the period 2017-2019 when these results are supported by the results from Berry 2020. In most cases, the results were supported by the results from the randomized and non-randomized studies. We found lower incidence of infections in the transperineal compared to the transrectal group (Tamhankar 2020: urinary tract infections: RR = 0.64 [95% CI: 0.56 to 0.74], general infections: RR = 0.45 [95% CI: 0.39 to 0.51], GRADE: low, table 01). The results for sepsis pointed in the same direction in all studies, but the incidence was higher in the transrectal group compared with the transperineal group (Tamhankar 2020: RR = 0.37 [95% CI: 0.32 to 0.44] Berry 2020: adjusted risk difference aRD = -0.4% [95% CI: - 0.6 to -0.2], GRADE: moderate). For hospital readmissions due to urinary retention, the incidence was higher in the transperineal compared with the transrectal group. The results of the randomized and non-randomized trials pointed in the same direction as the results in Berry 2020 and Tamhankar 2020 (Tamhankar 2020: RR = 3.08 [95% KI: 2.61 to 3.63]). The effect was large, but since twice as many samples were collected in the transperineal group as in the transrectal group, and the incidence of urinary retention is assumed to increase with the number of samples the results were not necessarily transferable (GRADE: low). The 30-day mortality rate was 0.07% in the transperineal group and 0.10% in the transrectal group in Berry 2020. In Tamhankar 2020, the percentages were, respectively, 0.05% and 0.07%. The certainty of the evidence was therefore considered to be very low due to few events. Three randomized and one non-randomized study reported pain during and immediately after the procedures. The study with the lowest risk of systematic bias and the highest number of patients found higher pain reported on a visual analog scale in the transperineal compared with the transrectal group (median 4 [IQR 1-6] versus 2 [IQR 0-4]). The results are supported by one of the three other studies (mean [SD] = 8.02 [2.0] versus 5.90 [1.5]), while two reported no difference between the groups. We rated the certainty of the evidence (GRADE) as low. Conclusion: Transperineal biopsy for suspected prostate cancer may reduce the number of infections and sepsis compared to transrectal biopsy. There is possibly a greater risk of urinary retention during the transperineal procedure, but these results are uncertain since the procedures used in the included studies do not fully correspond to the procedures that are relevant in Norway. Based on results from previously published systematic reviews, we did not find any indication that transperineal biopsy is inferior to transrectal biopsy in the detection of prostate cancer. Our economic analysis shows that the higher cost of the transperineal procedure could be offset by savings from lower costs for treating complications associated with this procedure. If the additional costs associated with implementing a transperineal procedure as a standard method for prostate biopsy do not exceed NOK 1,000 per procedure, the intervention can be cost saving for the health service.

Authors' methods: We searched for systematic reviews and then for primary studies that covered the inclusion criteria. After inclusion, we assessed methodological quality in the systematic reviews and the risk of bias in the primary studies. The relevant outcomes were infections, sepsis, urinary retention, (re)hospitalizations and pain. We calculated relative risk (RR) with a 95% confidence interval (CI) for dichotomous outcomes. We assessed the most important outcomes with the GRADE tool. Certainty of effect estimates, i.e., whether we have confidence that the effect estimate is close to a true underlying effect, is assessed with the GRADE tool as high, moderate, low, or very low. 11 Executive summary (English) We performed a simplified cost impact analysis to compare resource use for transperineal prostate biopsy with that of transrectal biopsy. We also compared costs of treating procedure-related complications of transperineal versus transrectal biopsies.

Project Status: Completed

URL for protocol: https://www.fhi.no/en/cristin-projects/ongoing/transperineal-biopsy-compared-with-transrectal-biopsy-in-suspected-prostate/

Year Published: 2022

URL for published report: https://www.fhi.no/globalassets/dokumenterfiler/rapporter/2022/transperineal-sammenliknet-med-transrektal-biopsitakning-ved-mistanke-om-prostatakreft-rapport-2022.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo