{
    "info": {
        "nct_id": "NCT06362291",
        "official_title": "Comparison of MRI Artificial Intelligence-guided Cognitive Fusion-targeted Biopsy Versus Routine Cognitive Fusion-targeted Prostate Biopsy in Prostate Cancer Diagnosis: a Prospective Randomized Controlled Trial",
        "inclusion_criteria": "1. The age of the patient is between 45 and 85.\n2. Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of Peking University First Hospital, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.\n3. Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.\n4. Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive years > 10ng/ml or PSA volume > 0.75/ml/ years). The time interval between the two prostate biopsies should be longer than three months.\n5. The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.\n6. Patients with complete clinical information.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 45 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "1. The mpMRI data was unqualified or incomplete.\n2. Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.\n3. The mpMRI of Peking University First Hospital did not find suspicious prostate lesions.\n4. Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.\n5. The patient could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study.\n6. Patients with incomplete clinical information.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. The age of the patient is between 45 and 85.",
            "criterions": [
                {
                    "exact_snippets": "age of the patient is between 45 and 85",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 45,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with complete multiparametric magnetic resonance imaging (mpMRI) data of Peking University First Hospital, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.",
            "criterions": [
                {
                    "exact_snippets": "complete multiparametric magnetic resonance imaging (mpMRI) data",
                    "criterion": "mpMRI data",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "qualified image quality control",
                    "criterion": "image quality control",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious lesions",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3",
                    "criterion": "PI-RADS V2.1",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.",
            "criterions": [
                {
                    "exact_snippets": "suspicious prostate nodes found by digital rectal examination (DRE)",
                    "criterion": "suspicious prostate nodes",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "digital rectal examination (DRE)"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious lesions found by transrectal ultrasound (TRUS)",
                    "criterion": "suspicious lesions",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "transrectal ultrasound (TRUS)"
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious lesions found by ... MRI",
                    "criterion": "suspicious lesions",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "total prostate-specific antigen (tPSA) >10ng/mL",
                    "criterion": "total prostate-specific antigen (tPSA)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tPSA 4-10ng/mL",
                    "criterion": "total prostate-specific antigen (tPSA)",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "free-to-total PSA ratio (f/tPSA) <0.16",
                    "criterion": "free-to-total PSA ratio (f/tPSA)",
                    "requirements": [
                        {
                            "requirement_type": "ratio",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.16,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA density (PSAD) >0.15",
                    "criterion": "PSA density (PSAD)",
                    "requirements": [
                        {
                            "requirement_type": "density",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.15,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients were in accordance with the indication of repeated prostate biopsy (patients with atypical acinar hyperplasia or high-grade intraepithelial neoplasia, especially when the pathological results of multi-needle puncture were as above; re-examination of PSA > 10 ng/ml; re-examination of PSA 4~10ng/ml, abnormal f/tPSA, abnormal PSAD, abnormal DRE, or imaging abnormalities; for patients with the results of re-examination of PSA 4~10ng/ml and with close follow-up, PSA for 2 consecutive years > 10ng/ml or PSA volume > 0.75/ml/ years). The time interval between the two prostate biopsies should be longer than three months.",
            "criterions": [
                {
                    "exact_snippets": "atypical acinar hyperplasia",
                    "criterion": "atypical acinar hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high-grade intraepithelial neoplasia",
                    "criterion": "high-grade intraepithelial neoplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological results of multi-needle puncture were as above",
                    "criterion": "pathological results of multi-needle puncture",
                    "requirements": [
                        {
                            "requirement_type": "consistency",
                            "expected_value": "atypical acinar hyperplasia or high-grade intraepithelial neoplasia"
                        }
                    ]
                },
                {
                    "exact_snippets": "re-examination of PSA > 10 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "re-examination of PSA 4~10ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "ng/ml"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "ng/ml"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal f/tPSA",
                    "criterion": "f/tPSA",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal PSAD",
                    "criterion": "PSAD",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal DRE",
                    "criterion": "DRE",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "imaging abnormalities",
                    "criterion": "imaging",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA for 2 consecutive years > 10ng/ml",
                    "criterion": "PSA level over 2 years",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA volume > 0.75/ml/ years",
                    "criterion": "PSA volume",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.75,
                                "unit": "ml/years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "time interval between the two prostate biopsies should be longer than three months",
                    "criterion": "time interval between prostate biopsies",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The targeted prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.",
            "criterions": [
                {
                    "exact_snippets": "The targeted prostate biopsy pathological results of above lesions were complete.",
                    "criterion": "targeted prostate biopsy pathological results",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.",
                    "criterion": "time interval between targeted prostate biopsy and prostate mpMRI examination",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with complete clinical information.",
            "criterions": [
                {
                    "exact_snippets": "complete clinical information",
                    "criterion": "clinical information",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "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 45 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 45 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. The mpMRI data was unqualified or incomplete.",
            "criterions": [
                {
                    "exact_snippets": "mpMRI data was unqualified",
                    "criterion": "mpMRI data",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mpMRI data was ... incomplete",
                    "criterion": "mpMRI data",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Patients had received radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients had received ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients had received ... androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients had received ... surgery treatment",
                    "criterion": "surgery treatment",
                    "requirements": [
                        {
                            "requirement_type": "received",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. The mpMRI of Peking University First Hospital did not find suspicious prostate lesions.",
            "criterions": [
                {
                    "exact_snippets": "mpMRI of Peking University First Hospital did not find suspicious prostate lesions",
                    "criterion": "suspicious prostate lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients were not in accordance with the indication of prostate biopsy or were not received systematic biopsy combined with targeted biopsy.",
            "criterions": [
                {
                    "exact_snippets": "not in accordance with the indication of prostate biopsy",
                    "criterion": "indication of prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "accordance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not received systematic biopsy combined with targeted biopsy",
                    "criterion": "systematic biopsy combined with targeted biopsy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. The patient could not cooperate to complete the systematic biopsy combined with targeted biopsy. The patients or their family members refused to participate in this study.",
            "criterions": [
                {
                    "exact_snippets": "The patient could not cooperate to complete the systematic biopsy combined with targeted biopsy.",
                    "criterion": "cooperation for biopsy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The patients or their family members refused to participate in this study.",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients with incomplete clinical information.",
            "criterions": [
                {
                    "exact_snippets": "incomplete clinical information",
                    "criterion": "clinical information",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}