TRANSLATE
Research type
Research Study
Full title
A randomised controlled trial of TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation (TRANSLATE) of potentially clinically significant prostate cancer
IRAS ID
293939
Contact name
Richard Bryant
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
ISRCTN Number
ISRCTN98159689
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Prostate cancer (PCa) is the second most common cancer in men in the United Kingdom (UK), with ~45,000 cases diagnosed per year. Initially a man will visit his General Practitioner (GP) if he notices issues with his waterworks. Where a GP feels a man needs to be referred to a hospital, the patients’ symptoms, and two simple tests called a Digital Rectal Examination (DRE) and Prostate Specific Antigen (PSA) are reviewed, and if appropriate the patient may be offered further tests for possible prostate cancer, such as a Magnetic Resonance Imaging (MRI) scan and a prostate biopsy.
The MRI scan allows detailed images of the prostate gland to be obtained, which may visually identify a possible cancer within the prostate gland. The patient may also be offered a prostate biopsy in order to obtain multiple small samples of the prostate tissue in order to identify if any growth is cancer.
Currently in the NHS - the biopsy can be undertaken by one of 2 methods - a Transrectal Ultrasound Guided Biopsy (TRUS biopsy) or a Local Anaesthetic Transperineal Biopsy (LATP biopsy). There is no evidence available as to which is best to detect cancer - hence the need for this study.
Men who agree to participate will have the type of biopsy they receive assigned by chance, and then data will be collected from them up to 4 months after their biopsy.
Whatever is found in the biopsy will be treated as per standard NHS treatments available in the patients local hospital.
The study aims to see which biopsy detect the most cancer and should be the one that is routinely used in men presenting at hospital for investigation of suspected prostate cancer going forward.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0274
Date of REC Opinion
14 Sep 2021
REC opinion
Favourable Opinion