Cost Effectiveness of Local Anaesthetic Transperineal Versus Transrectal Biopsy: Results from the TRANSLATE Study.
Little M., Wolstenholme J., Landeiro F., Marian IR., Williams R., Francisco Lopez J., Mercader C., Raslan M., Berridge C., Whitburn J., Campbell T., Tuck S., Barber VS., Scaife J., Hewitt A., Taylor A., Ooms A., Ghosh S., Reynard JM., Hamdy FC., Liew MPC., Leslie T., Catto JWF., Rosario DJ., Omer A., Good DW., Gray R., Kommu S., Chung D., Wells H., Narahari K., Macpherson RE., Verrill C., Eddy B., Yamamoto H., Bryant RJ., Lamb AD., TRANSLATE Trial Study Group .
BACKGROUND AND OBJECTIVE: A local anaesthetic ultrasound-guided transperineal (LATP) prostate biopsy has advantages over transrectal ultrasound (TRUS)-guided biopsy, with improved magnetic resonance imaging (MRI)-guided prostate cancer detection and lower rates of infection-related complications. However, uncertainty remains regarding the cost effectiveness of an LATP biopsy compared with a TRUS biopsy. METHODS: Between December 2021 and September 2023, the TRANSLATE randomised clinical trial allocated 1126 men to receive either a TRUS (n = 564) or an LATP (n = 562) biopsy at ten sites in the UK. All men were biopsy naïve and underwent prebiopsy MRI. Participants were followed up for 4 mo after a biopsy. The economic analysis is a within-trial analysis at 4 mo after biopsy, conducted from a National Health Service perspective. We assessed resource use, health care costs, and quality-adjusted life years (QALYs) across 4 mo of follow-up from an intention-to-treat perspective. We addressed missing data using multiple imputation. Incremental cost-effectiveness ratios were calculated, with uncertainty characterised using nonparametric bootstrapping. The TRANSLATE trial is registered at ISRCTN (ISRCTN98159689) and is complete. KEY FINDINGS AND LIMITATIONS: The total mean costs over the 4 mo of follow-up were £1062 in the LATP arm and £917 in the TRUS arm (adjusted mean difference £149; 95% confidence interval [CI] £61-236, p = 0.001). The total mean QALYs at 4 mo were 0.282 in the LATP arm and 0.284 in the TRUS arm (adjusted mean difference -0.004; 95% CI -0.009 to 0.001, p = 0.098). CONCLUSIONS AND CLINICAL IMPLICATIONS: An LATP biopsy has a higher mean cost, and no significant difference in mean QALYs, compared with a TRUS biopsy at 4 mo after the procedure. A time of 4 mo is too soon to reflect any impact from the 5.7% diagnostic uplift for LATP versus TRUS biopsy on the detection of intermediate-/high-grade prostate cancer seen in the TRANSLATE trial. A further analysis beyond this period is needed to fully interpret the cost-effectiveness results.