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

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 dis...

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Published in:	BJU international Vol. 131; no. 6; pp. 694 - 704
Main Authors:	Bryant, Richard J., Yamamoto, Hide, Eddy, Ben, Kommu, Sashi, Narahari, Krishna, Omer, Altan, Leslie, Tom, Catto, James W. F., Rosario, Derek J., Good, Daniel W., Gray, Rob, Liew, Matthew P. C., Lopez, J. Francisco, Campbell, Teresa, Reynard, John M., Tuck, Steve, Barber, Vicki S., Medeghri, Nadjat, Davies, Lucy, Parkes, Matthew, Hewitt, Aimi, Landeiro, Filipa, Wolstenholme, Jane, Macpherson, Ruth, Verrill, Clare, Marian, Ioana R., Williams, Roxanne, Hamdy, Freddie C., Lamb, Alastair D.
Format:	Journal Article
Language:	English
Published:	England Wiley Subscription Services, Inc 01-06-2023
Subjects:	Biopsy Biopsy - adverse effects Clinical significance Clinical trials clinically significant prostate cancer Humans Image-Guided Biopsy - adverse effects Image-Guided Biopsy - methods local anaesthetic Local anesthesia Magnetic resonance imaging Magnetic Resonance Imaging - methods Male Multicenter Studies as Topic Patients PCSM Prospective Studies Prostate Prostate - pathology Prostate cancer ProstateCancer Prostatic Neoplasms - diagnosis Prostatic Neoplasms - pathology Quality of Life Randomized Controlled Trials as Topic transperineal prostate biopsy transrectal prostate biopsy Ultrasonic imaging Ultrasound uroonc local anaesthetic uroonc clinically significant prostate cancer PCSM transperineal prostate biopsy ProstateCancer transrectal prostate biopsy Prostate cancer
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Summary:	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.
Bibliography:	R.J.B. and A.D.L. Co‐Principal Investigators and joint senior authors. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1464-4096 1464-410X
DOI:	10.1111/bju.15978