Protocol for the TRANSLATE prospective, multicentre, randomised clinical trial of prostate biopsy technique.

Autor:	Bryant RJ; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Yamamoto H; Department of Urology, Maidstone and Tunbridge Wells NHS Trust, Maidstone Hospital, Maidstone, UK., Eddy B; Department of Urology, East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK., Kommu S; Department of Urology, East Kent Hospitals University NHS Foundation Trust, Kent and Canterbury Hospital, Canterbury, UK., Narahari K; Department of Urology, Cardiff and Vale University Health Board, University Hospital of Wales, Cardiff, UK., Omer A; Department of Urology, University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, UK., Leslie T; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.; Department of Urology, Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes Hospital, Milton Keynes, UK., Catto JWF; Academic Urology Unit, University of Sheffield and Department of Urology, Sheffield University Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield, UK., Rosario DJ; Academic Urology Unit, University of Sheffield and Department of Urology, Sheffield University Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield, UK., Good DW; Department of Urology, NHS Lothian, Western General Hospital, Edinburgh, UK., Gray R; Department of Urology, Buckinghamshire Healthcare NHS Trust, Wycombe Hospital, High Wycombe, UK., Liew MPC; Department of Urology, Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust, Wigan, UK., Lopez JF; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK., Campbell T; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK., Reynard JM; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK., Tuck S; Oxfordshire Prostate Cancer Support Group, Oxford, UK., Barber VS; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Medeghri N; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Davies L; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Parkes M; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Hewitt A; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Landeiro F; Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK., Wolstenholme J; Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK., Macpherson R; Department of Radiology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK., Verrill C; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.; Department of Cellular Pathology, Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, UK., Marian IR; Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK., Williams R; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Hamdy FC; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Lamb AD; Department of Urology, Oxford University Hospitals NHS Foundation Trust, Churchill Hospital, Oxford, UK.; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
Jazyk:	angličtina
Zdroj:	BJU international [BJU Int] 2023 Jun; Vol. 131 (6), pp. 694-704. Date of Electronic Publication: 2023 Feb 21.
DOI:	10.1111/bju.15978
Abstrakt:	Objectives: Primary objectives: to determine whether local anaesthetic transperineal prostate (LATP) biopsy improves the detection of clinically significant prostate cancer (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥2 disease (i.e., any Gleason pattern 4 disease), compared to transrectal ultrasound-guided (TRUS) prostate biopsy, in biopsy-naïve men undergoing biopsy based on suspicion of csPCa. Secondary Objectives: to compare (i) infection rates, (ii) health-related quality of life, (iii) patient-reported procedure tolerability, (iv) patient-reported biopsy-related complications (including bleeding, bruising, pain, loss of erectile function), (v) number of subsequent prostate biopsy procedures required, (vi) cost-effectiveness, (vii) other histological parameters, and (viii) burden and rate of detection of clinically insignificant PCa (ISUP Grade Group 1 disease) in men undergoing these two types of prostate biopsy. Patients and Methods: The TRANSLATE trial is a UK-wide, multicentre, randomised clinical trial that meets the criteria for level-one evidence in diagnostic test evaluation. TRANSLATE is investigating whether LATP biopsy leads to a higher rate of detection of csPCa compared to TRUS prostate biopsy. Both biopsies are being performed with an average of 12 systematic cores in six sectors (depending on prostate size), plus three to five target cores per multiparametric/bi-parametric magnetic resonance imaging lesion. LATP biopsy is performed using an ultrasound probe-mounted needle-guidance device (either the 'Precision-Point' or BK UA1232 system). TRUS biopsy is performed according to each hospital's standard practice. The study is 90% powered to detect a 10% difference (LATP biopsy hypothesised at 55% detection rate for csPCa vs 45% for TRUS biopsy). A total of 1042 biopsy-naïve men referred with suspected PCa need to be recruited. Conclusions: This trial will provide robust prospective data to determine the diagnostic ability of LATP biopsy vs TRUS biopsy in the primary diagnostic setting. (© 2023 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)
Databáze:	MEDLINE
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