{
    "info": {
        "nct_id": "NCT02693860",
        "official_title": "A Pilot Study of Neoadjuvant Monoclonal Antibody Humanised (hu) J591 for the Treatment of High and/or Intermediate-Risk Prostate Cancer",
        "inclusion_criteria": "1. Adult male > 18 years of age\n2. Histologically confirmed diagnosis of prostate cancer\n3. Intermediate or high risk prostate cancer defined by:\n\n   * High risk (any one of the following):\n\n     1. Gleason grade > 8\n     2. Gleason grade 4+3 with more than 3 cores involved with > 20% of volume involved\n     3. Any Gleason with PSA above 20 ng/mL\n     4. Gleasone > 4+3 and tumor stage clinical T3 or above\n   * Intermediate risk prostate cancer defined as:\n\n     1. Gleason grade = 7\n     2. Any Gleason with PSA between 10 and 20 ng/mL\n4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1\n5. Ability to understand and willingness to sign a written informed consent document\n6. Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Serum creatinine > 3x upper limit of normal (ULN)\n2. Bilirubin (total) > 1.5 x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits\n3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT or SGOT) > 2.5x ULN\n4. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation\n5. On any other new anticancer therapy between screening and prostatectomy\n6. Frank metastasis identified during clinical staging\n7. Patient ineligible for radical prostatectomy for any other reason",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Adult male > 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Adult male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": " > 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histologically confirmed diagnosis of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed diagnosis of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Intermediate or high risk prostate cancer defined by:",
            "criterions": [
                {
                    "exact_snippets": "Intermediate or high risk prostate cancer",
                    "criterion": "prostate cancer risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "intermediate",
                                "high"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High risk (any one of the following):",
            "criterions": [
                {
                    "exact_snippets": "High risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Gleason grade > 8",
            "criterions": [
                {
                    "exact_snippets": "Gleason grade > 8",
                    "criterion": "Gleason grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Gleason grade 4+3 with more than 3 cores involved with > 20% of volume involved",
            "criterions": [
                {
                    "exact_snippets": "Gleason grade 4+3",
                    "criterion": "Gleason grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "4+3"
                        }
                    ]
                },
                {
                    "exact_snippets": "more than 3 cores involved",
                    "criterion": "cores involved",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cores"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "> 20% of volume involved",
                    "criterion": "volume involved",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any Gleason with PSA above 20 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Gleason",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA above 20 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Gleasone > 4+3 and tumor stage clinical T3 or above",
            "criterions": [
                {
                    "exact_snippets": "Gleasone > 4+3",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 4.3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor stage clinical T3 or above",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "T"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intermediate risk prostate cancer defined as:",
            "criterions": [
                {
                    "exact_snippets": "Intermediate risk prostate cancer",
                    "criterion": "prostate cancer risk level",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": "Intermediate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Gleason grade = 7",
            "criterions": [
                {
                    "exact_snippets": "Gleason grade = 7",
                    "criterion": "Gleason grade",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Any Gleason with PSA between 10 and 20 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Gleason",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA between 10 and 20 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 20,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1",
                    "criterion": "ECOG Performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Ability to understand and willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Prostate biopsy with + PSMA expression in tumor cells by immunohistochemistry",
            "criterions": [
                {
                    "exact_snippets": "Prostate biopsy",
                    "criterion": "prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "+ PSMA expression in tumor cells by immunohistochemistry",
                    "criterion": "PSMA expression in tumor cells",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": "immunohistochemistry"
                        },
                        {
                            "requirement_type": "presence",
                            "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": "Must be 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Serum creatinine > 3x upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine > 3x upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Bilirubin (total) > 1.5 x ULN; subjects with Gilbert's syndrome will be allowed if direct bilirubin is within institutional normal limits",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin (total) > 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gilbert's syndrome ... direct bilirubin is within institutional normal limits",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "direct bilirubin is within institutional normal limits",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "within institutional normal limits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT or SGOT) > 2.5x ULN",
            "criterions": [
                {
                    "exact_snippets": "Aspartate Aminotransferase (AST) ... > 2.5x ULN",
                    "criterion": "Aspartate Aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alanine Aminotransferase (ALT or SGOT) ... > 2.5x ULN",
                    "criterion": "Alanine Aminotransferase (ALT or SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation",
            "criterions": [
                {
                    "exact_snippets": "Other severe acute or chronic medical condition",
                    "criterion": "medical condition",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": [
                                "acute",
                                "chronic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. On any other new anticancer therapy between screening and prostatectomy",
            "criterions": [
                {
                    "exact_snippets": "On any other new anticancer therapy",
                    "criterion": "anticancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Frank metastasis identified during clinical staging",
            "criterions": [
                {
                    "exact_snippets": "Frank metastasis identified during clinical staging",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Patient ineligible for radical prostatectomy for any other reason",
            "criterions": [
                {
                    "exact_snippets": "ineligible for radical prostatectomy",
                    "criterion": "eligibility for radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}