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

niversity of Oxford0 sites1,042 target enrollmentJanuary 28, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 28, 2021

End Date

December 31, 2023

Last Updated

last year

Study Type

Interventional

Sex

Male

Sponsor

•All biopsy\-naïve men who (regardless of age), during an investigation for suspicion of possible PCa, require a prostate biopsy and who have had one or more of the below findings:
•1\. A PSA value above the age\-adjusted upper limit of normal, regardless of the MRI result
•2\. An abnormal pre\-biopsy MRI
•3\. An abnormal prostate DRE (regardless of serum PSA or MRI result)
•4\. Considered suitable to tolerate a LATP biopsy procedure

•1\. Had a previous prostate biopsy
•2\. Dysuria on the day of biopsy or untreated urinary tract infection (UTI)
•3\. Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate)
•4\. May need enhanced antibiotic prophylaxis (e.g. due to indwelling catheter or recurrent UTIs)
•5\. Previous abdominoperineal resection (i.e. absent rectum)
•6\. Unable to recline adequately in Lloyd\-Davis / lithotomy position (e.g. hip surgery or contractures)
•7\. Unable to have a pre\-biopsy MRI (e.g. pacemaker, eGFR \<50, or claustrophobia)
•8\. PSA \>50 ng/ml (i.e. locally advanced/metastatic PCa easily detectable by TRUS)