The TRANSLATE trial, a randomized controlled study, is designed to compare the clinical and economic effectiveness of two biopsy techniques in the detection of significant prostate cancer (PCa). This trial focuses on two methods: transrectal ultrasound-guided (TRUS) biopsy and local anaesthetic transperineal (LATP) biopsy. The outcomes of this study are highly anticipated, as they will provide crucial data on the best practices for prostate cancer diagnosis, potentially influencing future clinical guidelines.
The TRANSLATE trial evaluates the effectiveness of TRUS versus LATP biopsy in detecting clinically significant prostate cancer in biopsy-naïve men aged 18 and older. Participants were randomly assigned to undergo either TRUS or LATP biopsy. The primary endpoint is the detection rate of clinically significant PCa, defined as Gleason Grade Group ≥ 2. Secondary endpoints include patient-reported outcomes, such as the ProBE questionnaire and International Index of Erectile Function (IIEF), as well as clinical measures like infection rates and complications.
Study Design and Methodology
The study employs a parallel, superiority, multicentre RCT design with a 1:1 computer-generated random allocation. Detailed in the statistical analysis plan (SAP), the study outlines the sample size calculation, models for analysis, and the handling of missing data. Sensitivity and subgroup analyses are also pre-planned. The SAP was formulated and submitted without prior knowledge of the trial outcomes to ensure unbiased results.
Conducted across multiple centres, the trial also records secondary outcomes using various standardized questionnaires and scoring systems, including the International Prostate Symptom Score (IPSS) and EQ-5D-5L. These metrics will help evaluate patient quality of life and symptomatic changes post-biopsy.
Transparency and Data Integrity
The publication of the TRANSLATE trial SAP is aimed at enhancing the transparency of the trial’s data analysis and mitigating the risk of outcome reporting bias. Any deviations from the pre-specified SAP will be fully documented and justified in the final study report and subsequent publications.
The study is registered under the International Standard Randomised Controlled Trial Number ISRCTN98159689 and is also listed on ClinicalTrials.gov under the identifier NCT05179694, ensuring adherence to international standards for RCTs.
Key Takeaways for Clinical Practice
- TRUS and LATP biopsy methods are being rigorously compared for their effectiveness in detecting significant prostate cancer.
- Secondary outcomes will provide insights into patient quality of life and functional outcomes post-biopsy.
- Data from this trial could influence future clinical guidelines for prostate biopsy procedures.
- Transparency in the analysis plan aims to enhance the reliability and applicability of the trial findings.
The TRANSLATE trial’s comprehensive design and pre-specified SAP ensure that the results will be both robust and reliable. These findings are expected to have significant implications for clinical practice, potentially guiding the choice of biopsy methods for prostate cancer detection and optimizing patient outcomes.
Original Article: Trials. 2024 Jun 14;25(1):383. doi: 10.1186/s13063-024-08224-4. PMID: 38872174 | DOI: 10.1186/s13063-024-08224-4
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