ISRCTN98159689Completed未知
A randomised controlled trial of TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation (TRANSLATE) of potentially clinically significant prostate cancer (the TRANSLATE trial)
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- niversity of Oxford
- Enrollment
- 1,042
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Investigators
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