{
    "info": {
        "nct_id": "NCT05513820",
        "official_title": "Automatic Detection in MRI of Prostate Cancer: DAICAP",
        "inclusion_criteria": "* Patients with clinical suspicion of prostate cancer (increased PSA and/or abnormality on digital rectal examination) who underwent a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS < 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with histologically proven prostate cancer and/or treatment for prostate cancer prior to the diagnostic workup\n\nProspective substudy\n\nInclusion Criteria:\n\n* Patients with clinical suspicion of prostate cancer (increased PSA level and/or abnormality on digital rectal examination) who should receive a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS < 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software.\n\nExclusion Criteria:\n\n* Patients with already histologically proven cancer, patients who have received treatment for prostate cancer, patients who cannot benefit from prostate biopsies, or patients with a contraindication to performing mpMRI.",
        "miscellaneous_criteria": "Retrospective substudy"
    },
    "inclusion_lines": [
        {
            "line": "* Patients with clinical suspicion of prostate cancer (increased PSA and/or abnormality on digital rectal examination) who underwent a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS < 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software.",
            "criterions": [
                {
                    "exact_snippets": "clinical suspicion of prostate cancer",
                    "criterion": "clinical suspicion of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increased PSA",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormality on digital rectal examination",
                    "criterion": "digital rectal examination",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mpMRI",
                    "criterion": "mpMRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate biopsies",
                    "criterion": "prostate biopsies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PI-RADS < 3",
                    "criterion": "PI-RADS score",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PI-RADS ≥3",
                    "criterion": "PI-RADS score",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "Must be 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": "* Patients with histologically proven prostate cancer and/or treatment for prostate cancer prior to the diagnostic workup",
            "criterions": [
                {
                    "exact_snippets": "histologically proven prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment for prostate cancer prior to the diagnostic workup",
                    "criterion": "prostate cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to the diagnostic workup"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Prospective substudy",
            "criterions": [
                {
                    "exact_snippets": "Prospective substudy",
                    "criterion": "study type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "prospective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinical suspicion of prostate cancer (increased PSA level and/or abnormality on digital rectal examination) who should receive a diagnostic workup including mpMRI and prostate biopsies according to national recommendations: in case of normal mpMRI (PI-RADS < 3) 12 systematic samples; in case of pathological mpMRI (PI-RADS ≥3) 12 systematic samples associated with targeted samples (n= 2 to 4) by cognitive fusion, or image fusion software.",
            "criterions": [
                {
                    "exact_snippets": "clinical suspicion of prostate cancer",
                    "criterion": "clinical suspicion of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "increased PSA level",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormality on digital rectal examination",
                    "criterion": "abnormality on digital rectal examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "normal mpMRI (PI-RADS < 3)",
                    "criterion": "mpMRI PI-RADS score",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological mpMRI (PI-RADS ≥3)",
                    "criterion": "mpMRI PI-RADS score",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with already histologically proven cancer, patients who have received treatment for prostate cancer, patients who cannot benefit from prostate biopsies, or patients with a contraindication to performing mpMRI.",
            "criterions": [
                {
                    "exact_snippets": "histologically proven cancer",
                    "criterion": "cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "received treatment for prostate cancer",
                    "criterion": "prostate cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot benefit from prostate biopsies",
                    "criterion": "benefit from prostate biopsies",
                    "requirements": [
                        {
                            "requirement_type": "benefit",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindication to performing mpMRI",
                    "criterion": "mpMRI contraindication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Retrospective substudy",
            "criterions": [
                {
                    "exact_snippets": "Retrospective substudy",
                    "criterion": "study type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "retrospective"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "Inclusion Criteria:",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}