{
    "info": {
        "nct_id": "NCT00805701",
        "official_title": "Randomized, Double-Blind, Placebo-Controlled Trial Assessing The Efficacy And Safety Of Dutasteride At Improving Lower Urinary Tract Symptoms In Men With Clinically Localized Prostate Cancer Being Treated With Single-Dose Goserelin, Trans-Urethral Incision Of Prostate, And Interval Brachytherapy",
        "inclusion_criteria": "A subject will be eligible for inclusion in this study only if all of the following criteria apply:\n\n1. Must be male ≥35 and ≤90 years of age\n2. Have biopsy proven, localized prostate cancer\n3. Gleason score ≤ 8\n4. Clinical stage T1c-T2b\n5. Serum PSA (prostate specific antigen) ≤10ng/mL within the 12 months period prior to positive prostate biopsy.\n6. Able to swallow and retain oral medication\n7. Able and willing to participate in the full duration of the study\n8. Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 35 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "1. Subject has ever been treated for prostate cancer with any of the following:\n\n   * Radiotherapy (external beam or brachytherapy)\n   * Chemotherapy\n   * Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethyl-stilbestrol (DES)\n   * Oral glucocorticoids\n   * Gonadotropin Releasing Hormone (GnRH) analogues (e.g., leuprolide, goserelin) other than the single-dose gosereline given as treatment in this study.\n2. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one\n3. Current and/or previous use of the following medications:\n\n   * Finasteride (Proscar, Propecia), or Dutasteride (Avodart) exposure within 6 months prior to study entry are excluded.\n   * Any other investigational 5-reductase inhibitors within the past 12 months.\n   * Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)\n   * Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, progestational agents) *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Must be male ≥35 and ≤90 years of age",
            "criterions": [
                {
                    "exact_snippets": "Must be male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥35 and ≤90 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 35,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 90,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have biopsy proven, localized prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "biopsy proven",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "localized prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Gleason score ≤ 8",
            "criterions": [
                {
                    "exact_snippets": "Gleason score ≤ 8",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Clinical stage T1c-T2b",
            "criterions": [
                {
                    "exact_snippets": "Clinical stage T1c-T2b",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "T1c"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "T2b"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Serum PSA (prostate specific antigen) ≤10ng/mL within the 12 months period prior to positive prostate biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Serum PSA (prostate specific antigen) ≤10ng/mL",
                    "criterion": "serum PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within the 12 months period prior to positive prostate biopsy",
                    "criterion": "timeframe for serum PSA measurement",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within the 12 months period prior to positive prostate biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Able to swallow and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Able to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Able and willing to participate in the full duration of the study",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to participate in the full duration of the study",
                    "criterion": "participation ability and willingness",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Able to read and write",
                    "criterion": "literacy",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "understand instructions related to study procedures",
                    "criterion": "comprehension of study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give written informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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 35 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 35 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 35,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Subject has ever been treated for prostate cancer with any of the following:",
            "criterions": [
                {
                    "exact_snippets": "Subject has ever been treated for prostate cancer",
                    "criterion": "treatment for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Radiotherapy (external beam or brachytherapy)",
            "criterions": [
                {
                    "exact_snippets": "Radiotherapy (external beam or brachytherapy)",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "external beam",
                                "brachytherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethyl-stilbestrol (DES)",
            "criterions": [
                {
                    "exact_snippets": "Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethyl-stilbestrol (DES)",
                    "criterion": "hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "megestrol",
                                "medroxyprogesterone",
                                "cyproterone",
                                "diethyl-stilbestrol (DES)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oral glucocorticoids",
            "criterions": [
                {
                    "exact_snippets": "Oral glucocorticoids",
                    "criterion": "oral glucocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gonadotropin Releasing Hormone (GnRH) analogues (e.g., leuprolide, goserelin) other than the single-dose gosereline given as treatment in this study.",
            "criterions": [
                {
                    "exact_snippets": "Gonadotropin Releasing Hormone (GnRH) analogues (e.g., leuprolide, goserelin) other than the single-dose gosereline given as treatment in this study.",
                    "criterion": "GnRH analogues",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": "not allowed except single-dose gosereline given as treatment in this study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one",
            "criterions": [
                {
                    "exact_snippets": "Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one",
                    "criterion": "glucocorticoid use",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "inhaled",
                                "topical"
                            ]
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Current and/or previous use of the following medications:",
            "criterions": [
                {
                    "exact_snippets": "Current and/or previous use of the following medications",
                    "criterion": "use of specific medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Finasteride (Proscar, Propecia), or Dutasteride (Avodart) exposure within 6 months prior to study entry are excluded.",
            "criterions": [
                {
                    "exact_snippets": "Finasteride (Proscar, Propecia) ... exposure within 6 months prior to study entry are excluded.",
                    "criterion": "Finasteride exposure",
                    "requirements": [
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Dutasteride (Avodart) exposure within 6 months prior to study entry are excluded.",
                    "criterion": "Dutasteride exposure",
                    "requirements": [
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other investigational 5-reductase inhibitors within the past 12 months.",
            "criterions": [
                {
                    "exact_snippets": "investigational 5-reductase inhibitors within the past 12 months",
                    "criterion": "investigational 5-reductase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)",
            "criterions": [
                {
                    "exact_snippets": "Anabolic steroids (subject must discontinued for 6 months prior to study entry",
                    "criterion": "anabolic steroids",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, progestational agents) *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.",
            "criterions": [
                {
                    "exact_snippets": "Drugs with antiandrogenic properties within the past 6 months",
                    "criterion": "use of drugs with antiandrogenic properties",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of cimetidine is permitted prior to study entry",
                    "criterion": "use of cimetidine",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of topical ketoconazole is permitted prior to and during the study",
                    "criterion": "use of topical ketoconazole",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "A subject will be eligible for inclusion in this study only if all of the following criteria apply:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}