{
    "info": {
        "nct_id": "NCT01512472",
        "official_title": "Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy",
        "inclusion_criteria": "* histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated\n* PSA level meeting both of these criteria:\n* PSA level of ≥ 5 ng/mL.\n* For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.\n* screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)\n* Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "intermittent endocrine treatment therapy is indicated",
                    "criterion": "intermittent endocrine treatment therapy",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA level meeting both of these criteria:",
            "criterions": [
                {
                    "exact_snippets": "PSA level meeting both of these criteria",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "both of these criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA level of ≥ 5 ng/mL.",
            "criterions": [
                {
                    "exact_snippets": "PSA level of ≥ 5 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir.",
            "criterions": [
                {
                    "exact_snippets": "recurrence after radiotherapy or cryotherapy",
                    "criterion": "recurrence after radiotherapy or cryotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir",
                    "criterion": "serum PSA",
                    "requirements": [
                        {
                            "requirement_type": "comparison to PSA nadir",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.",
            "criterions": [
                {
                    "exact_snippets": "screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL.",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.2,
                                "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"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)",
            "criterions": [
                {
                    "exact_snippets": "previous or is currently under hormonal management of prostate cancer",
                    "criterion": "hormonal management of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "previous",
                                "current"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical castration",
                    "criterion": "surgical castration",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other hormonal manipulation",
                    "criterion": "hormonal manipulation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening",
            "criterions": [
                {
                    "exact_snippets": "Has received therapy with the 5-alpha reductase inhibitors finasteride ... within 12 weeks ... prior to screening",
                    "criterion": "finasteride therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received therapy with the 5-alpha reductase inhibitors ... dutasteride within ... 25 weeks ... prior to screening",
                    "criterion": "dutasteride therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 25,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}