A randomised controlled trial of TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation (TRANSLATE) of potential clinically significant prostate cancer

Research Hypothesis: LATP biopsy improves detection of clinically significant PCa, and decreases infection rates, compared to TRUS biopsy.

Background: Prostate cancer (PCa) is the commonest cancer in men in the United Kingdom (UK), with ~45,000 cases diagnosed per year. 100,000 men each year in the UK are referred for biopsy for suspected PCa based on prostate-specific antigen (PSA) testing and/or abnormal digital rectal examination (DRE). The optimal method of clinic biopsy to detect significant PCa, and limit infection risk, is uncertain.

Aims / Objectives: To assess the efficacy of LATP versus TRUS biopsy in detecting clinically significant PCa; and to provide evidence-based information about the differences in biopsy-related complications, cost-effectiveness and patient-reported outcomes between these two biopsy options.

Methods: A prospective, multi-centre, open-label RCT of LATP versus TRUS biopsy; the setting will be a minimum of nine large Urology departments across UK NHS hospitals. We aim to recruit 1042 biopsy-naïve men referred with suspected PCa based on an elevated age-specific PSA or abnormal DRE, suitable for investigation with pre-biopsy magnetic resonance imaging (MRI) and prostate biopsy.

Men will be randomised 1:1 to LATP prostate biopsy, performed with an average of ~12 systematic biopsy cores in 6 sectors depending on prostate size, with an additional ~4 target biopsy cores for each radiologically significant lesion seen on pre-biopsy MRI, using an LATP device according to local centre practice, versus TRUS prostate biopsy, performed according to each hospital’s standard practice, with an average of ~12 systematic biopsy cores in two sectors depending on prostate size, with an additional ~4 target biopsy cores. The primary outcome is detection rates of clinically significant PCa, defined by presence of any Gleason pattern 4 disease; secondary outcomes will assess rates of infection (to include: all symptoms of infection, general practitioner (GP) prescribed treatment for infection, readmissions to hospital for infection, and microbiologically proven infection), Health related quality of life (HRQoL), patient reported tolerability of the procedure, patient reported biopsy-related complications (including bleeding, bruising, pain, loss of erectile function), number of subsequent prostate biopsy procedures, cost-effectiveness and histological parameters. Men will be followed up at baseline, 7 days, 35 days and 4 month post-randomisation.

Timelines for delivery: The total length of the trial is 31 months. Recruitment will last for 15 months. There will be a formal stop/go review of the internal pilot in month 12 of the project (after 6 months of recruitment) to ensure a minimum of 140 patients have been randomised and 4 centres have been opened to recruitment. If the target is met, the trial will continue to recruit for a further 9 months. Data from the patients in the internal pilot phase will be included in the final analysis.

Anticipated impact and dissemination: We anticipate that the study results have potential to affect over 100,000 men in the UK annually, given the number of men undergoing prostate biopsies. The findings are likely to extend beyond the UK and dissemination will be through publications, presentations and appropriate use of media. A full patient and public involvement (PPI) programme is included.