Prostate Cancer Clinical Trial
— TRANSLATEOfficial title:
A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer
The TRANSLATE randomised controlled trial aims to evaluate local anaesthetic transperineal biopsy (LATP) versus transrectal ultrasound-guided (TRUS) prostate biopsy, in the evaluation of previously biopsy-naive men being investigated for clinically significant prostate cancer (on the basis of an elevated age-specific PSA, or abnormal digital rectal examination, or MRI-visible lesion). Men under investigation for possible prostate cancer and recruited to TRANSLATE will be randomised to receive either an LATP or TRUS prostate biopsy, with the primary outcome measure being detection of clinically significant prostate cancer (defined as any Gleason pattern 4 disease, i.e. any Gleason Grade Group >=2 disease). Secondary outcome measures include infection, other complications, tolerability, rate of re-biopsy, detection of clinically insignificant prostate cancer, and a full health economics evaluation.
Status | Recruiting |
Enrollment | 1042 |
Est. completion date | October 31, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: All biopsy-naïve men aged 18 years and over who, during investigation for suspicion of possible prostate cancer, require a prostate biopsy. This includes: - A PSA value above the age-adjusted upper limit of normal, regardless of the MRI result, OR An abnormal pre-biopsy MRI on a 1.5 Tesla or higher MRI scanner, OR An abnormal prostate DRE (regardless of serum PSA or MRI result) - Considered suitable to tolerate an LATP biopsy procedure by the local clinical team - Able to give informed consent - Able to understand written English to enable completion of study validated patient reported outcome measures (questionnaires). Exclusion Criteria: The participant may not enter the study if ANY of the following apply: - Any previous prostate biopsy - Dysuria on the day of biopsy or untreated urinary tract infection (UTI) - Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate) - May need enhanced antibiotic prophylaxis: Indwelling catheter, recurrent UTIs - Previous abdomino-perineal resection (i.e. absent rectum) - Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery, contractures) - Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR <50, claustrophobia) - PSA >50 ng/ml (i.e. locally advanced/metastatic prostate cancer easily detectable by TRUS). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Department of Urology, Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | National Institute for Health Research, United Kingdom |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of clinically significant prostate cancer. | Clinically significant prostate cancer (as defined by the presence of Gleason Grade Group =2 prostate cancer, i.e. any Gleason pattern =4 disease). | 4 weeks | |
Secondary | Infection | Post-biopsy infection - patient questionnaire reporting. | 7 days, 35 days, and 4 months post procedure. | |
Secondary | Health-related quality of life. | Patient reporting. | At baseline, 7 days, 35 days and 4 months post procedure. | |
Secondary | Patient reported tolerability of the procedure. | ProBE questionnaire. | Immediately post-procedure. | |
Secondary | Patient reported biopsy-related complications. | ProBE questionnaire. | 7 days post-procedure. | |
Secondary | Number of subsequent prostate biopsy procedures required. | Patient reporting. | 7 days, 35 days, and 4 months post procedure. | |
Secondary | Cost-effectiveness. | Resource use questionnaire. | Baseline, 7 days, 35 days and 4 months post procedure. | |
Secondary | Histological parameters (ISUP grade group, cancer core length, core involvement, target biopsy cancer parameters). | Histology reporting of grading of biopsy samples as per local reporting practices. | Within 4 weeks of biopsy. | |
Secondary | Serious adverse events incidence. | Patient questionnaires. | Up to 4 months post procedure. |
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