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
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.
Summary of Results:
Patients referred for specialist investigation for possible prostate cancer, on the basis of either an elevated age-specific Prostate Specific Antigen (PSA) blood test result, or a suspicious digital rectal examination (DRE) of the prostate, will usually receive a magnetic resonance imaging (MRI) scan of the prostate, followed by a prostate biopsy. The prostate biopsy aims to sample the prostate gland through placement of a biopsy needle to obtain small samples of prostate tissue for inspection under the microscope by a pathologist. This approach will identify prostate cancer if it is present, and in these cases the pathologist will assign a Gleason grade group (GGG), this being a marker of how aggressive the prostate cancer is expected to behave, thus guiding treatment recommendations for patients. Currently around 70,000 prostate biopsy procedures are performed each year in the UK to investigate men at risk of having prostate cancer. There has been an ongoing debate and considerable uncertainty regarding the best approach to undertake prostate biopsies in the diagnostic pathway. For decades, the conventional approach to prostate biopsies has been through the transrectal route (TRUS) where the biopsy needles are placed through the rectu (back passage) and into the prostate gland under local anaesthetic in the clinic. However, in recent years, transperineal prostate biopsy under local anaesthetic (LATP), where the biopsy needles pass through the skin between the scrotum and the back passage and into the prostate, has been developed as an alternative approach, aiming to improve cancer detection and reduce rates of post-biopsy infection. However, there has been an absence of robust level 1 evidence to inform clinical practice, with adoption of LATP on an ad-hoc basis, driven by enthusiasts, leading to inequality of access to each type of biopsy.
The TRANSLATE trial aimed to robustly evaluate LATP versus TRUS biopsy in previously biopsy naïve individuals who had received a pre-biopsy MRI scan, in terms of prostate cancer detection as a “Primary Outcome”, but also for important “Secondary Outcomes” such as infection and other post-biopsy complications (such as bleeding, difficulty passing urine afterwards, or difficulty with sexual function), tolerability, discomfort and embarrassment, need for a repeat biopsy procedure, and health economics. Between Dec 3, 2001, and September 26, 2023, 2078 (76%) of 2727 assessed individuals across 10 NHS hospitals in the UK were found to be eligible for the TRANSLATE study, and 1126 (41%) of 2727 agreed to participate. 1044 (93%) of the 1126 participants were White British. Participants were allocated to TRUS (n=564) or LATP (n=562) biopsy, and were followed up at time of biopsy, and at 7 days, 35 days, and 4 months after the biopsy procedure. We found “clinically significant prostate cancer” (which we defined as GGG 2 or higher disease) in 329 (60.1%) of 547 participants with biopsy results randomly assigned to LATP compared with 294 (54.4%) of 540 participants with biopsy results randomly assigned to TRUS biopsy (odds ratio [OR] 1·32 [95% CI 1·03-1·70]; p=0·031). Infection requiring admission to hospital within 35 days of the biopsy procedure occurred in 2 (<1%) of 562 participants in the LATP group compared with 9 (2%) of 564 in the TRUS group. No statistically significant difference was observed in the reporting of overall biopsy-related complications (LATP 454 [81%] of 562 vs TRUS 436 [77%] of 564, OR 1·23 [95% CI 0·93 to 1·65]), urinary retention requiring insertion of an indwelling urinary catheter (LATP 35 [6%] of 562 vs TRUS 27 [5%] of 564), urinary symptoms, nor sexual function at 4 months after biopsy. Trial participants more commonly reported LATP biopsy to be immediately painful and embarrassing compared with TRUS (LATP 216 [38%] of 562 vs TRUS 153 [27%] of 564; OR 1·84 [95% CI 1·40 to 2·43]). Serious adverse events occurred in 14 (2%) of 562 participants in the LATP group and 25 (4%) of 564 in the TRUS group. An LATP biopsy has a higher mean cost (£1062), and no significant difference in mean QALYs, compared with a TRUS biopsy (£917) at 4 months after the procedure, though a time of 4 months is too soon to reflect any impact from the 5.7% diagnostic uplift for LATP versus TRUS biopsy on the detection of intermediate-/high-grade prostate cancer seen in the TRANSLATE trial.
In summary, among biopsy-naive individuals being investigated for possible prostate cancer, biopsy with LATP led to greater detection of GGG 2 or higher prostate cancer compared with TRUS. These findings will help to inform patients, clinicians, clinical guidelines, and policy makers regarding the important trade-offs between LATP and TRUS prostate biopsy.
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