{
    "info": {
        "nct_id": "NCT00769548",
        "official_title": "A PHASE III TRIAL COMPARING WHOLE PELVIC IRRADIATION FOLLOWED BY A CONEDOWN BOOST TO BOOST IRRADIATION ONLY AND COMPARING NEOADJUVANT TO ADJUVANT TOTAL ANDROGEN SUPPRESSION (TAS)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided by a conversion factor of approximately 1.5 GS determination required prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study)\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery"
    },
    "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": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Any stage with an estimated risk of node involvement at least 15% (and therefore at significant risk for local and/or systemic failure) based on pretreatment PSA and Gleason score (GS), e.g.: GS of 7 and PSA greater than 7.5 ng/mL GS of 6 and PSA greater than 22.5 ng/mL GS of 5 and PSA greater than 37.5 ng/mL PSA greater than 4 and less than 100 ng/mL Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL may need to be divided by a conversion factor of approximately 1.5 GS determination required prior to entry No distant metastases No biopsy proven lymph node involvement Ineligible for protocol RTOG-9408 (clinical stages T2c-T4 with GS of 6 or higher are eligible for this study)",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Any stage with an estimated risk of node involvement at least 15%",
                    "criterion": "risk of node involvement",
                    "requirements": [
                        {
                            "requirement_type": "estimated risk",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "pretreatment PSA and Gleason score (GS)",
                    "criterion": "pretreatment PSA and Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "GS",
                            "expected_value": [
                                ">=7 and PSA > 7.5 ng/mL",
                                ">=6 and PSA > 22.5 ng/mL",
                                ">=5 and PSA > 37.5 ng/mL"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA greater than 4 and less than 100 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 4,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 100,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Highest pretreatment value determined by a monoclonal assay that has a normal range of 0-4 ng/mL",
                    "criterion": "PSA pretreatment value",
                    "requirements": [
                        {
                            "requirement_type": "determination method",
                            "expected_value": "monoclonal assay"
                        },
                        {
                            "requirement_type": "normal range",
                            "expected_value": "0-4 ng/mL"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA measured by polyclonal assay (e.g., Yang) that has a normal range of 0-2.5 ng/mL",
                    "criterion": "PSA measurement method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "polyclonal assay"
                        },
                        {
                            "requirement_type": "normal range",
                            "expected_value": "0-2.5 ng/mL"
                        }
                    ]
                },
                {
                    "exact_snippets": "GS determination required prior to entry",
                    "criterion": "GS determination",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "required prior to entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "No distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No biopsy proven lymph node involvement",
                    "criterion": "biopsy proven lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Ineligible for protocol RTOG-9408",
                    "criterion": "eligibility for protocol RTOG-9408",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical stages T2c-T4 with GS of 6 or higher are eligible for this study",
                    "criterion": "clinical stage and GS",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T2c-T4"
                        },
                        {
                            "requirement_type": "GS",
                            "expected_value": ">=6"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Liver function tests no greater than 1.2 times normal Renal: Not specified Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up No second malignancy within 5 years except superficial nonmelanomatous skin cancer",
            "criterions": [
                {
                    "exact_snippets": "Age: Any age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Karnofsky 70-100%",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Not specified",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Liver function tests no greater than 1.2 times normal",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "liver function tests",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.2,
                                "unit": "times normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Not specified",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other: No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up",
                    "criterion": "major medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No second malignancy within 5 years except superficial nonmelanomatous skin cancer",
                    "criterion": "second malignancy within 5 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "exception",
                            "expected_value": "superficial nonmelanomatous skin cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: At least 90 days since testosterone At least 60 days since finasteride Radiotherapy: No prior radiotherapy Surgery: No more than 60 days since surgical staging No radical surgery or cryosurgery",
            "criterions": [
                {
                    "exact_snippets": "No prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 90 days since testosterone",
                    "criterion": "time since testosterone",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 60 days since finasteride",
                    "criterion": "time since finasteride",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior radiotherapy",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No more than 60 days since surgical staging",
                    "criterion": "time since surgical staging",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No radical surgery or cryosurgery",
                    "criterion": "radical surgery or cryosurgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}