{
    "info": {
        "nct_id": "NCT00586898",
        "official_title": "Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle",
        "inclusion_criteria": "-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.\n\nB. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%\n\n* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.\n* Patient must have level of serum testosterone above the lower limit of normal.\n* Karnofskcy performance status (KPS) >_70%.\n* Patients must have adequate organ function as defined by the following laboratory criteria:\n* WBC >_3500/mm3, platelet count >_100,000/mm3.\n* Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.\n* Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.\n* Prior hormonal therapy is allowed as:\n\n  1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.\n  2. One cycle of intermittent therapy up to a maximum exposure of 10 months.\n* Patients must be at least 18 years of age.\n* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.\n* Uncontrolled serious active infection.\n* Anticipated survival of less than 3 months.\n* Active CNS or epiduraltumor\n* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "-Patients residing in the following clinical states wit! be considered: A. Rising PSA: Patients with a history of localized disease who have undergone definitive radiation or surgery. These patients must demonstrate progression of disease biochemically as outlined below. Patients in this group may not have radiographically evident disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients residing in the following clinical states"
                    ],
                    "criterion": "clinical state",
                    "requirement_type": "residence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Rising PSA"
                    ],
                    "criterion": "PSA",
                    "requirement_type": "trend",
                    "expected_value": "rising"
                },
                {
                    "exact_snippets": [
                        "history of localized disease"
                    ],
                    "criterion": "localized disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "undergone definitive radiation or surgery"
                    ],
                    "criterion": "definitive treatment",
                    "requirement_type": "history",
                    "expected_value": [
                        "radiation",
                        "surgery"
                    ]
                },
                {
                    "exact_snippets": [
                        "demonstrate progression of disease biochemically"
                    ],
                    "criterion": "disease progression",
                    "requirement_type": "biochemical evidence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "may not have radiographically evident disease"
                    ],
                    "criterion": "radiographically evident disease",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "B. Non-castrate metastatic: Patients must present with radiographic evidence of metastatic disease at the time of diagnosis or after treatment for localized disease. These patients must show newly detected disease or progressing disease in bone or in soft tissue. Biochemical progression is defined as: minimum no. of determinations: 3 Interval: >2 weeks Minimal Baseline PSA value (ng/ml): 2 Minimal % increase in range of values: 50%",
            "criterions": [
                {
                    "exact_snippets": [
                        "radiographic evidence of metastatic disease"
                    ],
                    "criterion": "metastatic disease",
                    "requirement_type": "evidence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "newly detected disease or progressing disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "status",
                    "expected_value": [
                        "newly detected",
                        "progressing"
                    ]
                },
                {
                    "exact_snippets": [
                        "in bone or in soft tissue"
                    ],
                    "criterion": "disease location",
                    "requirement_type": "presence",
                    "expected_value": [
                        "bone",
                        "soft tissue"
                    ]
                },
                {
                    "exact_snippets": [
                        "Biochemical progression is defined as"
                    ],
                    "criterion": "biochemical progression",
                    "requirement_type": "definition",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "minimum no. of determinations: 3"
                    ],
                    "criterion": "number of determinations",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 3
                    }
                },
                {
                    "exact_snippets": [
                        "Interval: >2 weeks"
                    ],
                    "criterion": "interval between determinations",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">",
                        "value": 2
                    }
                },
                {
                    "exact_snippets": [
                        "Minimal Baseline PSA value (ng/ml): 2"
                    ],
                    "criterion": "baseline PSA value",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 2
                    }
                },
                {
                    "exact_snippets": [
                        "Minimal % increase in range of values: 50%"
                    ],
                    "criterion": "percentage increase in PSA",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 50
                    }
                }
            ]
        },
        {
            "line": "* Diagnosis of prostate adenocarcinoma histologically confirmed at MSKCC.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosis of prostate adenocarcinoma"
                    ],
                    "criterion": "prostate adenocarcinoma",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "histologically confirmed"
                    ],
                    "criterion": "histological confirmation",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "at MSKCC"
                    ],
                    "criterion": "confirmation location",
                    "requirement_type": "location",
                    "expected_value": "MSKCC"
                }
            ]
        },
        {
            "line": "* Patient must have level of serum testosterone above the lower limit of normal.",
            "criterions": [
                {
                    "exact_snippets": [
                        "level of serum testosterone",
                        "above the lower limit of normal"
                    ],
                    "criterion": "serum testosterone",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 0
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Karnofskcy performance status (KPS) >_70%.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Karnofskcy performance status (KPS) >_70%"
                    ],
                    "criterion": "Karnofsky performance status",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 70
                    }
                }
            ]
        },
        {
            "line": "* Patients must have adequate organ function as defined by the following laboratory criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "adequate organ function"
                    ],
                    "criterion": "organ function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* WBC >_3500/mm3, platelet count >_100,000/mm3.",
            "criterions": [
                {
                    "exact_snippets": [
                        "WBC >_3500/mm3"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3500
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "platelet count >_100,000/mm3"
                    ],
                    "criterion": "platelet",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 100000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Bilirubin <2.0 mg/dl or SGOT <3.0 X the upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Bilirubin <2.0 mg/dl"
                    ],
                    "criterion": "bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2.0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "SGOT <3.0 X the upper limit of normal"
                    ],
                    "criterion": "SGOT",
                    "requirement_type": "level",
                    "expected_value": "<3.0 X the upper limit of normal"
                }
            ]
        },
        {
            "line": "* Creatinine <_1.6 mg/dl or creatinine clearance >_60 cc/min.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Creatinine <_1.6 mg/dl"
                    ],
                    "criterion": "creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "creatinine clearance >_60 cc/min"
                    ],
                    "criterion": "creatinine clearance",
                    "requirement_type": "rate",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 60
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Prior hormonal therapy is allowed as:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior hormonal therapy is allowed"
                    ],
                    "criterion": "hormonal therapy",
                    "requirement_type": "prior allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "1. Neoadjuvant treatment prior to radiation therapy or radical prostatectomy, provided that the total duration of exposure does not exceed 10 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Neoadjuvant treatment prior to radiation therapy or radical prostatectomy"
                    ],
                    "criterion": "neoadjuvant treatment",
                    "requirement_type": "timing",
                    "expected_value": "prior to radiation therapy or radical prostatectomy"
                },
                {
                    "exact_snippets": [
                        "total duration of exposure does not exceed 10 months"
                    ],
                    "criterion": "neoadjuvant treatment",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. One cycle of intermittent therapy up to a maximum exposure of 10 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "One cycle of intermittent therapy"
                    ],
                    "criterion": "intermittent therapy",
                    "requirement_type": "cycle",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "maximum exposure of 10 months"
                    ],
                    "criterion": "therapy exposure",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must be at least 18 years of age"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "* Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "signed an informed consent document"
                    ],
                    "criterion": "informed consent document",
                    "requirement_type": "signed",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "understand the investigational nature of the proposed treatment"
                    ],
                    "criterion": "investigational nature of the proposed treatment",
                    "requirement_type": "understanding",
                    "expected_value": true
                }
            ]
        },
        {
            "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 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Clinically significant cardiac disease (New York Heart Association Class III/IV),or severe debilitating puhnonary disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinically significant cardiac disease",
                        "New York Heart Association Class III/IV"
                    ],
                    "criterion": "cardiac disease",
                    "requirement_type": "severity",
                    "expected_value": "New York Heart Association Class III/IV"
                },
                {
                    "exact_snippets": [
                        "severe debilitating puhnonary disease"
                    ],
                    "criterion": "pulmonary disease",
                    "requirement_type": "severity",
                    "expected_value": "severe debilitating"
                }
            ]
        },
        {
            "line": "* Uncontrolled serious active infection.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled serious active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Uncontrolled serious active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "severity",
                    "expected_value": "serious"
                },
                {
                    "exact_snippets": [
                        "Uncontrolled serious active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "activity",
                    "expected_value": "active"
                }
            ]
        },
        {
            "line": "* Anticipated survival of less than 3 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Anticipated survival of less than 3 months"
                    ],
                    "criterion": "anticipated survival",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Active CNS or epiduraltumor",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active CNS"
                    ],
                    "criterion": "CNS tumor",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "epidural tumor"
                    ],
                    "criterion": "epidural tumor",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability or unwillingness to comply with the treatment protocol"
                    ],
                    "criterion": "treatment protocol compliance",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Inability or unwillingness to comply with the follow-up"
                    ],
                    "criterion": "follow-up compliance",
                    "requirement_type": "ability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Inability or unwillingness to comply with the research tests"
                    ],
                    "criterion": "research tests compliance",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}