{
    "info": {
        "nct_id": "NCT03979573",
        "official_title": "Prospective Phase II Trial Evaluating Multiparametric MRI, Radiomics, MR-guided Biopsy, and Molecular Markers for Active Surveillance of Patients With Low- and Intermediate-Risk Prostate Cancer",
        "inclusion_criteria": "* Patients with a Gleason score of 3+3=6 or 3+4=7a and ≤ 33% of positive biopsy cores verified by an at least 12 core systematic prostate biopsy (SB)\n* Organ-confined disease (≤cT2a), note: tumor-positive biopsies in both lobes with non-palpable tumor are rated as cT1c\n* PSA value ≤10 ng/ml\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Gleason score ≥4+3=7b or a Gleason score 3+4=7a with positive biopsy cores >33% of all cores in SB\n* PSA >10 ng/ml\n* Patients not able to give informed consent\n* Contraindication to mp-MRI\n* Contraindication to prostate biopsy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with a Gleason score of 3+3=6 or 3+4=7a and ≤ 33% of positive biopsy cores verified by an at least 12 core systematic prostate biopsy (SB)",
            "criterions": [
                {
                    "exact_snippets": "Gleason score of 3+3=6 or 3+4=7a",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "3+3=6",
                                "3+4=7a"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "≤ 33% of positive biopsy cores",
                    "criterion": "positive biopsy cores",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 33,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "verified by an at least 12 core systematic prostate biopsy (SB)",
                    "criterion": "systematic prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "core count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "core"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Organ-confined disease (≤cT2a), note: tumor-positive biopsies in both lobes with non-palpable tumor are rated as cT1c",
            "criterions": [
                {
                    "exact_snippets": "Organ-confined disease (≤cT2a)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "cT"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor-positive biopsies in both lobes",
                    "criterion": "tumor-positive biopsies",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "both lobes"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-palpable tumor",
                    "criterion": "tumor palpability",
                    "requirements": [
                        {
                            "requirement_type": "palpability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA value ≤10 ng/ml",
            "criterions": [
                {
                    "exact_snippets": "PSA value ≤10 ng/ml",
                    "criterion": "PSA value",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Gleason score ≥4+3=7b or a Gleason score 3+4=7a with positive biopsy cores >33% of all cores in SB",
            "criterions": [
                {
                    "exact_snippets": "Gleason score ≥4+3=7b",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "b"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score 3+4=7a with positive biopsy cores >33% of all cores",
                    "criterion": "Gleason score with positive biopsy cores",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "a"
                            }
                        },
                        {
                            "requirement_type": "positive biopsy cores",
                            "expected_value": {
                                "operator": ">",
                                "value": 33,
                                "unit": "% of all cores"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA >10 ng/ml",
            "criterions": [
                {
                    "exact_snippets": "PSA >10 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients not able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients not able to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to mp-MRI",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to mp-MRI",
                    "criterion": "mp-MRI",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to prostate biopsy",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to prostate biopsy",
                    "criterion": "prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}