A study that aims to find out in the NHS what is the best way to take a prostate biopsy to determine if a man has prostate cancer (the TRANSLATE trial)
- Conditions
- Suspected prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN98159689
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 1042
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinically significant prostate cancer (PCa), defined as Gleason Grade Group =2, detected using LATP/TRUS biopsy within 5 days of the samples being taken
- Secondary Outcome Measures
Name Time Method