{
    "info": {
        "nct_id": "NCT05179694",
        "official_title": "A Randomised Controlled Trial Comparing TRANSrectal Biopsy Versus Local Anaethetic Transperineal Biopsy in Evaluation (TRANSLATE) of Men With Potential Clinically Significant Prostate Cancer",
        "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:\n\n* 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)\n* Considered suitable to tolerate an LATP biopsy procedure by the local clinical team\n* Able to give informed consent\n* Able to understand written English to enable completion of study validated patient reported outcome measures (questionnaires).\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "The participant may not enter the study if ANY of the following apply:\n\n* Any previous prostate biopsy\n* Dysuria on the day of biopsy or untreated urinary tract infection (UTI)\n* Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate)\n* May need enhanced antibiotic prophylaxis: Indwelling catheter, recurrent UTIs\n* Previous abdomino-perineal resection (i.e. absent rectum)\n* Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery, contractures)\n* Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR <50, claustrophobia)\n* PSA >50 ng/ml (i.e. locally advanced/metastatic prostate cancer easily detectable by TRUS).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "All biopsy-naïve men aged 18 years and over who, during investigation for suspicion of possible prostate cancer, require a prostate biopsy. This includes:",
            "criterions": [
                {
                    "exact_snippets": "biopsy-naïve",
                    "criterion": "biopsy history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                },
                {
                    "exact_snippets": "men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years and over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicion of possible prostate cancer",
                    "criterion": "prostate cancer suspicion",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "suspicion"
                        }
                    ]
                },
                {
                    "exact_snippets": "require a prostate biopsy",
                    "criterion": "prostate biopsy requirement",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 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)",
            "criterions": [
                {
                    "exact_snippets": "PSA value above the age-adjusted upper limit of normal",
                    "criterion": "PSA value",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "> age-adjusted upper limit of normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal pre-biopsy MRI on a 1.5 Tesla or higher MRI scanner",
                    "criterion": "pre-biopsy MRI",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "scanner strength",
                            "expected_value": ">= 1.5 Tesla"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal prostate DRE",
                    "criterion": "prostate DRE",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Considered suitable to tolerate an LATP biopsy procedure by the local clinical team",
            "criterions": [
                {
                    "exact_snippets": "Considered suitable to tolerate an LATP biopsy procedure",
                    "criterion": "LATP biopsy procedure tolerance",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to understand written English to enable completion of study validated patient reported outcome measures (questionnaires).",
            "criterions": [
                {
                    "exact_snippets": "Able to understand written English",
                    "criterion": "understanding of written English",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any previous prostate biopsy",
            "criterions": [
                {
                    "exact_snippets": "Any previous prostate biopsy",
                    "criterion": "previous prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Dysuria on the day of biopsy or untreated urinary tract infection (UTI)",
            "criterions": [
                {
                    "exact_snippets": "Dysuria on the day of biopsy",
                    "criterion": "dysuria",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "on the day of biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated urinary tract infection (UTI)",
                    "criterion": "urinary tract infection (UTI)",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate)",
            "criterions": [
                {
                    "exact_snippets": "Immunocompromised (due to history of prior immunocompromising medical condition",
                    "criterion": "immunocompromised",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Immunocompromised ... medications e.g. steroids or methotrexate",
                    "criterion": "immunocompromising medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May need enhanced antibiotic prophylaxis: Indwelling catheter, recurrent UTIs",
            "criterions": [
                {
                    "exact_snippets": "Indwelling catheter",
                    "criterion": "indwelling catheter",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent UTIs",
                    "criterion": "recurrent UTIs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous abdomino-perineal resection (i.e. absent rectum)",
            "criterions": [
                {
                    "exact_snippets": "Previous abdomino-perineal resection (i.e. absent rectum)",
                    "criterion": "abdomino-perineal resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery, contractures)",
            "criterions": [
                {
                    "exact_snippets": "Unable to recline adequately in Lloyd-Davis / lithotomy position",
                    "criterion": "ability to recline in Lloyd-Davis / lithotomy position",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hip surgery",
                    "criterion": "hip surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contractures",
                    "criterion": "contractures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR <50, claustrophobia)",
            "criterions": [
                {
                    "exact_snippets": "Unable to have a pre-biopsy MRI ... pacemaker",
                    "criterion": "pre-biopsy MRI",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "presence of pacemaker",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable to have a pre-biopsy MRI ... eGFR <50",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "ability to have pre-biopsy MRI",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Unable to have a pre-biopsy MRI ... claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "ability to have pre-biopsy MRI",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA >50 ng/ml (i.e. locally advanced/metastatic prostate cancer easily detectable by TRUS).",
            "criterions": [
                {
                    "exact_snippets": "PSA >50 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced/metastatic prostate cancer",
                    "criterion": "prostate cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable by TRUS",
                    "criterion": "detectability by TRUS",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "The participant may not enter the study if ANY of the following apply:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}