{
    "info": {
        "nct_id": "NCT00849082",
        "official_title": "Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have maximum age of 79 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven prostatic adenocarcinoma of the following TNM stages and WHO grades: T1 or T2 and grade G3 T3 or T4 and any histologic grade No evidence of distant metastases No evidence of positive common iliac or para-aortic lymph nodes Confirmed by bone scan, chest x-ray, negative ultrasound or CT of the liver, and CT of the retroperitoneum and/or bipedal lymphangiography Extraperitoneal pelvic lymph node biopsy may be either positive or negative provided stage and grade criteria are met\n\nPATIENT CHARACTERISTICS: Age: Under 80 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of second malignancy except basal cell skin carcinoma\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior radical prostatectomy No prior transperitoneal lymph node staging"
    },
    "inclusion_lines": [
        {
            "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": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 79 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 79 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 79,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "PATIENT CHARACTERISTICS: Age: Under 80 Performance status: WHO 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No history of second malignancy except basal cell skin carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Age: Under 80",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 80,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: WHO 0-2",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": "WHO"
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Not specified",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Not specified",
                    "criterion": "hepatic",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Not specified",
                    "criterion": "renal",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No history of second malignancy except basal cell skin carcinoma",
                    "criterion": "history of second malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "basal cell skin carcinoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: No prior radical prostatectomy No prior transperitoneal lymph node staging",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy for prostate cancer",
                    "criterion": "prior chemotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior hormonal therapy for prostate cancer",
                    "criterion": "prior hormonal therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radiotherapy for prostate cancer",
                    "criterion": "prior radiotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radical prostatectomy",
                    "criterion": "prior radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior transperitoneal lymph node staging",
                    "criterion": "prior transperitoneal lymph node staging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically proven prostatic adenocarcinoma of the following TNM stages and WHO grades: T1 or T2 and grade G3 T3 or T4 and any histologic grade No evidence of distant metastases No evidence of positive common iliac or para-aortic lymph nodes Confirmed by bone scan, chest x-ray, negative ultrasound or CT of the liver, and CT of the retroperitoneum and/or bipedal lymphangiography Extraperitoneal pelvic lymph node biopsy may be either positive or negative provided stage and grade criteria are met",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven prostatic adenocarcinoma",
                    "criterion": "prostatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM stages and WHO grades: T1 or T2 and grade G3",
                    "criterion": "TNM stage and WHO grade",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": "G3"
                        }
                    ]
                },
                {
                    "exact_snippets": "TNM stages and WHO grades: T3 or T4 and any histologic grade",
                    "criterion": "TNM stage and WHO grade",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T3",
                                "T4"
                            ]
                        },
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of positive common iliac or para-aortic lymph nodes",
                    "criterion": "positive common iliac or para-aortic lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed by bone scan, chest x-ray, negative ultrasound or CT of the liver, and CT of the retroperitoneum and/or bipedal lymphangiography",
                    "criterion": "confirmation methods",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "bone scan",
                                "chest x-ray",
                                "negative ultrasound or CT of the liver",
                                "CT of the retroperitoneum",
                                "bipedal lymphangiography"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Extraperitoneal pelvic lymph node biopsy may be either positive or negative provided stage and grade criteria are met",
                    "criterion": "extraperitoneal pelvic lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": [
                                "positive",
                                "negative"
                            ]
                        }
                    ]
                }
            ]
        }
    ]
}