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Trial reportTrials2024

Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial.

Ioana R Marian, Alexander Ooms, Jane Holmes, Matthew J Parkes, Alastair D Lamb, Richard J Bryant

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05179694 (A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05179694 naunknown statusnot on this map

A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer

TypeinterventionalSponsorUniversity of OxfordRan2021 to 2023Enrolled1,042ConditionsProstate CancerArmsProstate biopsy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ioana R MarianOxford Clinical Trials Research Unit, University of Oxford, Botnar Research Centre, Old Road OX3 7LD, Oxford, UK. ioana.marian@csm.ox.ac.uk.ORCID http://orcid.org/0000-0002-0692-8112
Alexander OomsOxford Clinical Trials Research Unit, University of Oxford, Botnar Research Centre, Old Road OX3 7LD, Oxford, UK.
Jane HolmesNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.
Matthew J ParkesOxford Clinical Trials Research Unit, University of Oxford, Botnar Research Centre, Old Road OX3 7LD, Oxford, UK.
Alastair D Lamb *Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.
Richard J Bryant *Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.

Funding

Health Technology Assessment Programme NIHR131233
6 · The paper itself

Abstract

backgroundThe TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation) trial assesses the clinical and cost-effectiveness of two biopsy procedures in terms of detection of clinically significant prostate cancer (PCa). This article describes the statistical analysis plan (SAP) for the TRANSLATE randomised controlled trial (RCT). METHODS/

designTRANSLATE is a parallel, superiority, multicentre RCT. Biopsy-naïve men aged ≥ 18 years requiring a prostate biopsy for suspicion of possible PCa are randomised (computer-generated 1:1 allocation ratio) to one of two biopsy procedures: transrectal (TRUS) or local anaesthetic transperineal (LATP) biopsy. The primary outcome is the difference in detection rates of clinically significant PCa (defined as Gleason Grade Group ≥ 2, i.e. any Gleason pattern ≥ 4 disease) between the two biopsy procedures. Secondary outcome measures are th eProBE questionnaire (Perception Part and General Symptoms) and International Index of Erectile Function (IIEF, Domain A) scores, International Prostate Symptom Score (IPSS) values, EQ-5D-5L scores, resource use, infection rates, complications, and serious adverse events. We describe in detail the sample size calculation, statistical models used for the analysis, handling of missing data, and planned sensitivity and subgroup analyses. This SAP was pre-specified, written and submitted without prior knowledge of the trial results. DISCUSSION: Publication of the TRANSLATE trial SAP aims to increase the transparency of the data analysis and reduce the risk of outcome reporting bias. Any deviations from the current SAP will be described and justified in the final study report and results publication.

trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN98159689, registered on 28 January 2021 and registered on the ClinicalTrials.gov (NCT05179694) trials registry.

Indexed as

Prostatic NeoplasmsAnesthesia, LocalBiopsyCost-Benefit AnalysisData Interpretation, StatisticalHumansMaleNeoplasm GradingPerineumPredictive Value of TestsProstateRectumCancer biopsyCancer diagnosisProstate cancerRandomised controlled trialStatistical analysis plan

Identifiers

PMID38872174
PMCPMC11177457

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.