{
    "info": {
        "nct_id": "NCT01581749",
        "official_title": "Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer",
        "inclusion_criteria": "* histologically proven prostate adenocarcinoma within 1 year of enrollment\n* Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0\n* Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0\n* ECOG Performance Status 0-1\n* No prior prostate radiation or other definitive therapy\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 21 Years",
        "exclusion_criteria": "* implanted hardware or other material that would prohibit treatment planning or delivery\n* chemotherapy for a malignancy within the previous 5 years\n* history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years\n* hormone ablation for 2 months prior to treatment or during treatment",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histologically proven prostate adenocarcinoma within 1 year of enrollment",
            "criterions": [
                {
                    "exact_snippets": [
                        "histologically proven prostate adenocarcinoma"
                    ],
                    "criterion": "prostate adenocarcinoma",
                    "requirement_type": "confirmation method",
                    "expected_value": "histologically proven"
                },
                {
                    "exact_snippets": [
                        "within 1 year of enrollment"
                    ],
                    "criterion": "diagnosis timing",
                    "requirement_type": "time since diagnosis",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0",
            "criterions": [
                {
                    "exact_snippets": [
                        "Gleason <or=6"
                    ],
                    "criterion": "Gleason score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "PSA <or=10"
                    ],
                    "criterion": "PSA level",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Clinical Stage T1b-T2a"
                    ],
                    "criterion": "clinical stage",
                    "requirement_type": "range",
                    "expected_value": [
                        "T1b",
                        "T2a"
                    ]
                },
                {
                    "exact_snippets": [
                        "Nx or N0"
                    ],
                    "criterion": "nodal involvement",
                    "requirement_type": "status",
                    "expected_value": [
                        "Nx",
                        "N0"
                    ]
                },
                {
                    "exact_snippets": [
                        "Mx or M0"
                    ],
                    "criterion": "metastasis",
                    "requirement_type": "status",
                    "expected_value": [
                        "Mx",
                        "M0"
                    ]
                }
            ]
        },
        {
            "line": "* Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0",
            "criterions": [
                {
                    "exact_snippets": [
                        "Gleason <or=6"
                    ],
                    "criterion": "Gleason score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "PSA<or=10"
                    ],
                    "criterion": "PSA level",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Clinical Stage T2b"
                    ],
                    "criterion": "Clinical Stage",
                    "requirement_type": "specific stage",
                    "expected_value": "T2b"
                },
                {
                    "exact_snippets": [
                        "Gleason=7"
                    ],
                    "criterion": "Gleason score",
                    "requirement_type": "exact value",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "PSA<or=10"
                    ],
                    "criterion": "PSA level",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Clinical Stage T1b-T2b"
                    ],
                    "criterion": "Clinical Stage",
                    "requirement_type": "range",
                    "expected_value": [
                        "T1b",
                        "T2b"
                    ]
                },
                {
                    "exact_snippets": [
                        "Gleason <or=6"
                    ],
                    "criterion": "Gleason score",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "PSA > 10 & < or =20"
                    ],
                    "criterion": "PSA level",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 10
                            },
                            {
                                "operator": "<=",
                                "value": 20
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Clinical Stage T1b- T2b"
                    ],
                    "criterion": "Clinical Stage",
                    "requirement_type": "range",
                    "expected_value": [
                        "T1b",
                        "T2b"
                    ]
                },
                {
                    "exact_snippets": [
                        "Nx or NO"
                    ],
                    "criterion": "N stage",
                    "requirement_type": "specific stage",
                    "expected_value": [
                        "Nx",
                        "N0"
                    ]
                },
                {
                    "exact_snippets": [
                        "Mx or M0"
                    ],
                    "criterion": "M stage",
                    "requirement_type": "specific stage",
                    "expected_value": [
                        "Mx",
                        "M0"
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status 0-1",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG Performance Status 0-1"
                    ],
                    "criterion": "ECOG Performance Status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* No prior prostate radiation or other definitive therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "No prior prostate radiation"
                    ],
                    "criterion": "prostate radiation",
                    "requirement_type": "prior treatment",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "No prior",
                        "other definitive therapy"
                    ],
                    "criterion": "definitive therapy",
                    "requirement_type": "prior treatment",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be MALE"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific value",
                    "expected_value": "male"
                }
            ]
        },
        {
            "line": "Must have minimum age of 21 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 21 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 21
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* implanted hardware or other material that would prohibit treatment planning or delivery",
            "criterions": [
                {
                    "exact_snippets": [
                        "implanted hardware or other material"
                    ],
                    "criterion": "implanted hardware or other material",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "would prohibit treatment planning or delivery"
                    ],
                    "criterion": "treatment planning or delivery",
                    "requirement_type": "prohibition",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* chemotherapy for a malignancy within the previous 5 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "chemotherapy for a malignancy within the previous 5 years"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of an invasive malignancy",
                        "other than this prostate cancer,or basal or squamous skin cancers"
                    ],
                    "criterion": "invasive malignancy",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within prior 5 years"
                    ],
                    "criterion": "invasive malignancy",
                    "requirement_type": "timeframe",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* hormone ablation for 2 months prior to treatment or during treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "hormone ablation"
                    ],
                    "criterion": "hormone ablation",
                    "requirement_type": "timing",
                    "expected_value": "2 months prior to treatment or during treatment"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}