{
    "info": {
        "nct_id": "NCT06636682",
        "official_title": "A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy",
        "inclusion_criteria": "* Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification.\n* Has ≥3 prostate biopsy cores with ≥50% tumor involvement.\n* Has PSA >4 ng/mL ≤28 days prior to enrollment.\n* Has no evidence of distant metastases based on PSMA-PET/CT performed ≤28 days prior to enrollment.\n* Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.\n* Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.\n* Has a life expectancy >5 years.\n\nAdditional key eligibility criteria immediately postoperative for inclusion in the randomized population include:\n\n* Stage >pT3a (tumor has extended outside of the prostate on one side).\n* Gleason score of 8, 9, or 10 (high/very high) on prostatectomy specimen.\n* Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.\n* Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.\n* Subjects must have negative surgical margins or microscopic-only positive surgical margins.\n\nFinal eligibility criteria at 2 months postoperative for randomization include:\n\n* FK-PC101 has been produced for the subject and meets all release specifications.\n* An undetectable PSA (<0.04 ng/mL) on the most recent test performed prior to randomization (Day -4 to -7).\n* No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer disease recurrence [such as PSA recurrence]).\n* Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:\n\n  * Absolute neutrophil count (ANC) >1000/µL\n  * Platelet count >100,000/µL.\n  * Hemoglobin >8.0 gm/dL.\n  * Estimated glomerular filtration rate (eGFR) >60 mL/minute based on Cockcroft-Gault formula.\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both <2 × upper limit of normal (ULN).\n  * Albumin >3.0 gm/dL.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal carcinoma, and melanoma in situ).\n* Is eligible for and elects to receive adjuvant therapy following RP.\n* Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).\n* Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.\n* Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.\n* Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.\n* Is currently receiving systemic steroid therapy at a prednisone equivalent dose of >10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.\n* Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.\n* Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification.",
                "criterions": [
                    {
                        "exact_snippets": "localized high-risk or very high-risk prostate cancer",
                        "criterion": "prostate cancer risk level",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "localized high-risk",
                                "very high-risk"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "NCCN v4.2023 classification",
                        "criterion": "NCCN classification version",
                        "requirement": {
                            "requirement_type": "version",
                            "expected_value": "v4.2023"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "localized high-risk or very high-risk prostate cancer",
                                "criterion": "prostate cancer risk level",
                                "requirement": {
                                    "requirement_type": "classification",
                                    "expected_value": [
                                        "localized high-risk",
                                        "very high-risk"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "NCCN v4.2023 classification",
                                "criterion": "NCCN classification version",
                                "requirement": {
                                    "requirement_type": "version",
                                    "expected_value": "v4.2023"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has ≥3 prostate biopsy cores with ≥50% tumor involvement.",
                "criterions": [
                    {
                        "exact_snippets": "≥3 prostate biopsy cores",
                        "criterion": "prostate biopsy cores",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≥50% tumor involvement",
                        "criterion": "tumor involvement",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "≥3 prostate biopsy cores",
                        "criterion": "prostate biopsy cores",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "≥50% tumor involvement",
                        "criterion": "tumor involvement",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has PSA >4 ng/mL ≤28 days prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "PSA >4 ng/mL ≤28 days prior to enrollment",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 4,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "PSA >4 ng/mL ≤28 days prior to enrollment",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "≤28 days prior to enrollment"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "PSA >4 ng/mL ≤28 days prior to enrollment",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 4,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "PSA >4 ng/mL ≤28 days prior to enrollment",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "≤28 days prior to enrollment"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has no evidence of distant metastases based on PSMA-PET/CT performed ≤28 days prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "no evidence of distant metastases",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "PSMA-PET/CT performed ≤28 days prior to enrollment",
                        "criterion": "PSMA-PET/CT",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "no evidence of distant metastases",
                        "criterion": "distant metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "PSMA-PET/CT performed ≤28 days prior to enrollment",
                        "criterion": "PSMA-PET/CT",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "Is a candidate for radical prostatectomy",
                        "criterion": "candidate for radical prostatectomy",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled radical prostatectomy date must be 3 to 14 days after enrollment",
                        "criterion": "scheduled radical prostatectomy date",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Is a candidate for radical prostatectomy",
                        "criterion": "candidate for radical prostatectomy",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled radical prostatectomy date must be 3 to 14 days after enrollment",
                        "criterion": "scheduled radical prostatectomy date",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.",
                "criterions": [
                    {
                        "exact_snippets": "Has not received ... neoadjuvant (preoperative) radiation therapy",
                        "criterion": "neoadjuvant radiation therapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "plans to receive neoadjuvant (preoperative) radiation therapy",
                        "criterion": "neoadjuvant radiation therapy",
                        "requirement": {
                            "requirement_type": "planned receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has not received ... androgen deprivation therapy (ADT)",
                        "criterion": "androgen deprivation therapy (ADT)",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "plans to receive ... androgen deprivation therapy (ADT)",
                        "criterion": "androgen deprivation therapy (ADT)",
                        "requirement": {
                            "requirement_type": "planned receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Has not received ... any other anticancer therapy",
                        "criterion": "any other anticancer therapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "plans to receive ... any other anticancer therapy",
                        "criterion": "any other anticancer therapy",
                        "requirement": {
                            "requirement_type": "planned receipt",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has not received ... neoadjuvant (preoperative) radiation therapy",
                                "criterion": "neoadjuvant radiation therapy",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "plans to receive neoadjuvant (preoperative) radiation therapy",
                                "criterion": "neoadjuvant radiation therapy",
                                "requirement": {
                                    "requirement_type": "planned receipt",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has not received ... androgen deprivation therapy (ADT)",
                                "criterion": "androgen deprivation therapy (ADT)",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "plans to receive ... androgen deprivation therapy (ADT)",
                                "criterion": "androgen deprivation therapy (ADT)",
                                "requirement": {
                                    "requirement_type": "planned receipt",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has not received ... any other anticancer therapy",
                                "criterion": "any other anticancer therapy",
                                "requirement": {
                                    "requirement_type": "receipt",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "plans to receive ... any other anticancer therapy",
                                "criterion": "any other anticancer therapy",
                                "requirement": {
                                    "requirement_type": "planned receipt",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a life expectancy >5 years.",
                "criterions": [
                    {
                        "exact_snippets": "life expectancy >5 years",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "life expectancy >5 years",
                        "criterion": "life expectancy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Additional key eligibility criteria immediately postoperative for inclusion in the randomized population include:",
                "criterions": [
                    {
                        "exact_snippets": "immediately postoperative",
                        "criterion": "postoperative status",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "immediate"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "immediately postoperative",
                        "criterion": "postoperative status",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "immediate"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Stage >pT3a (tumor has extended outside of the prostate on one side).",
                "criterions": [
                    {
                        "exact_snippets": "Stage >pT3a (tumor has extended outside of the prostate on one side)",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "pT"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Stage >pT3a (tumor has extended outside of the prostate on one side)",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "pT"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Gleason score of 8, 9, or 10 (high/very high) on prostatectomy specimen.",
                "criterions": [
                    {
                        "exact_snippets": "Gleason score of 8, 9, or 10 (high/very high)",
                        "criterion": "Gleason score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "8",
                                "9",
                                "10"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "prostatectomy specimen",
                        "criterion": "prostatectomy specimen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Gleason score of 8, 9, or 10 (high/very high)",
                        "criterion": "Gleason score",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "8",
                                "9",
                                "10"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "prostatectomy specimen",
                        "criterion": "prostatectomy specimen",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.",
                "criterions": [
                    {
                        "exact_snippets": "Pelvic lymph node dissection (PLND) is required",
                        "criterion": "pelvic lymph node dissection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "either pN0 or pN1 nodal staging permitted",
                        "criterion": "nodal staging",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "pN0",
                                "pN1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Pelvic lymph node dissection (PLND) is required",
                        "criterion": "pelvic lymph node dissection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "either pN0 or pN1 nodal staging permitted",
                        "criterion": "nodal staging",
                        "requirement": {
                            "requirement_type": "allowed values",
                            "expected_value": [
                                "pN0",
                                "pN1"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Subjects must have negative surgical margins or microscopic-only positive surgical margins.",
                "criterions": [
                    {
                        "exact_snippets": "negative surgical margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "microscopic-only positive surgical margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "microscopic-only positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "negative surgical margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    },
                    {
                        "exact_snippets": "microscopic-only positive surgical margins",
                        "criterion": "surgical margins",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "microscopic-only positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Final eligibility criteria at 2 months postoperative for randomization include:",
                "criterions": [
                    {
                        "exact_snippets": "2 months postoperative",
                        "criterion": "postoperative period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "2 months postoperative",
                        "criterion": "postoperative period",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* FK-PC101 has been produced for the subject and meets all release specifications.",
                "criterions": [
                    {
                        "exact_snippets": "FK-PC101 has been produced for the subject",
                        "criterion": "FK-PC101 production",
                        "requirement": {
                            "requirement_type": "production",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "meets all release specifications",
                        "criterion": "release specifications",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "FK-PC101 has been produced for the subject",
                        "criterion": "FK-PC101 production",
                        "requirement": {
                            "requirement_type": "production",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "meets all release specifications",
                        "criterion": "release specifications",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* An undetectable PSA (<0.04 ng/mL) on the most recent test performed prior to randomization (Day -4 to -7).",
                "criterions": [
                    {
                        "exact_snippets": "An undetectable PSA (<0.04 ng/mL)",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.04,
                                "unit": "ng/mL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "An undetectable PSA (<0.04 ng/mL)",
                        "criterion": "PSA level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.04,
                                "unit": "ng/mL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer disease recurrence [such as PSA recurrence]).",
                "criterions": [
                    {
                        "exact_snippets": "No prior, current, or planned future postoperative or adjuvant XRT",
                        "criterion": "postoperative or adjuvant XRT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior, current, or planned future ... hormonal therapy such as ADT",
                        "criterion": "hormonal therapy such as ADT",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "No prior, current, or planned future ... any other anticancer therapy",
                        "criterion": "anticancer therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "No prior, current, or planned future postoperative or adjuvant XRT",
                                            "criterion": "postoperative or adjuvant XRT",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    },
                                    {
                                        "not_criteria": {
                                            "exact_snippets": "No prior, current, or planned future ... hormonal therapy such as ADT",
                                            "criterion": "hormonal therapy such as ADT",
                                            "requirement": {
                                                "requirement_type": "presence",
                                                "expected_value": false
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "No prior, current, or planned future ... any other anticancer therapy",
                                    "criterion": "anticancer therapy",
                                    "requirement": {
                                        "requirement_type": "presence",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function based on CBC and chemistry studies",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "CBC",
                        "criterion": "CBC",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chemistry studies",
                        "criterion": "chemistry studies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 2 weeks of Day 1 (Day -14 to -7)",
                        "criterion": "timing of tests",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks of Day 1 (Day -14 to -7)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adequate organ function based on CBC and chemistry studies",
                                "criterion": "organ function",
                                "requirement": {
                                    "requirement_type": "adequacy",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "CBC",
                                "criterion": "CBC",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "chemistry studies",
                                "criterion": "chemistry studies",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "within 2 weeks of Day 1 (Day -14 to -7)",
                        "criterion": "timing of tests",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks of Day 1 (Day -14 to -7)"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Absolute neutrophil count (ANC) >1000/µL",
                "criterions": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >1000/µL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "µL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >1000/µL",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "µL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Platelet count >100,000/µL.",
                "criterions": [
                    {
                        "exact_snippets": "Platelet count >100,000/µL.",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Platelet count >100,000/µL.",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Hemoglobin >8.0 gm/dL.",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin >8.0 gm/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "gm/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Hemoglobin >8.0 gm/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8.0,
                                "unit": "gm/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Estimated glomerular filtration rate (eGFR) >60 mL/minute based on Cockcroft-Gault formula.",
                "criterions": [
                    {
                        "exact_snippets": "Estimated glomerular filtration rate (eGFR) >60 mL/minute",
                        "criterion": "estimated glomerular filtration rate (eGFR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/minute"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Estimated glomerular filtration rate (eGFR) >60 mL/minute",
                        "criterion": "estimated glomerular filtration rate (eGFR)",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL/minute"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both <2 × upper limit of normal (ULN).",
                "criterions": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... <2 × upper limit of normal (ULN).",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... <2 × upper limit of normal (ULN).",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Aspartate aminotransferase (AST) ... <2 × upper limit of normal (ULN).",
                        "criterion": "aspartate aminotransferase (AST)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "alanine aminotransferase (ALT) ... <2 × upper limit of normal (ULN).",
                        "criterion": "alanine aminotransferase (ALT)",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "× ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Albumin >3.0 gm/dL.",
                "criterions": [
                    {
                        "exact_snippets": "Albumin >3.0 gm/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "gm/dL"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Albumin >3.0 gm/dL",
                        "criterion": "albumin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "gm/dL"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Capable of giving signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "compliance with the requirements and restrictions of the study",
                        "criterion": "study compliance",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Capable of giving signed informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "compliance with the requirements and restrictions of the study",
                        "criterion": "study compliance",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal carcinoma, and melanoma in situ).",
                "criterions": [
                    {
                        "exact_snippets": "Has an additional active malignancy",
                        "criterion": "additional active malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "past cancer history (active malignancy within 2 years prior to study entry)",
                        "criterion": "past cancer history",
                        "requirement": {
                            "requirement_type": "time since active malignancy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal carcinoma, and melanoma in situ)",
                        "criterion": "concomitant neoplastic diagnoses",
                        "requirement": {
                            "requirement_type": "specific diagnoses",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "carcinomas in situ",
                                "breast DCIS",
                                "transitional cell carcinoma/NMIBC",
                                "anal carcinoma",
                                "melanoma in situ"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "not_criteria": {
                            "exact_snippets": "Has an additional active malignancy",
                            "criterion": "additional active malignancy",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "or_criteria": [
                            {
                                "not_criteria": {
                                    "exact_snippets": "past cancer history (active malignancy within 2 years prior to study entry)",
                                    "criterion": "past cancer history",
                                    "requirement": {
                                        "requirement_type": "time since active malignancy",
                                        "expected_value": {
                                            "operator": "<=",
                                            "value": 2,
                                            "unit": "years"
                                        }
                                    }
                                }
                            },
                            {
                                "exact_snippets": "non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal carcinoma, and melanoma in situ)",
                                "criterion": "concomitant neoplastic diagnoses",
                                "requirement": {
                                    "requirement_type": "specific diagnoses",
                                    "expected_value": [
                                        "non-melanoma skin cancer",
                                        "carcinomas in situ",
                                        "breast DCIS",
                                        "transitional cell carcinoma/NMIBC",
                                        "anal carcinoma",
                                        "melanoma in situ"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is eligible for and elects to receive adjuvant therapy following RP.",
                "criterions": [
                    {
                        "exact_snippets": "Is eligible for ... adjuvant therapy",
                        "criterion": "adjuvant therapy eligibility",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "elects to receive adjuvant therapy",
                        "criterion": "adjuvant therapy election",
                        "requirement": {
                            "requirement_type": "election",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Is eligible for ... adjuvant therapy",
                        "criterion": "adjuvant therapy eligibility",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "elects to receive adjuvant therapy",
                        "criterion": "adjuvant therapy election",
                        "requirement": {
                            "requirement_type": "election",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant cardiovascular disease",
                        "criterion": "cardiovascular disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "NYHA Class",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "NYHA Class"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "pulmonary embolism or stroke within 6 months prior to study entry",
                        "criterion": "pulmonary embolism or stroke",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "clinically significant arrhythmias not controlled by medication",
                        "criterion": "arrhythmias",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "clinically significant arrhythmias not controlled by medication",
                        "criterion": "arrhythmias",
                        "requirement": {
                            "requirement_type": "control by medication",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically significant cardiovascular disease",
                                "criterion": "cardiovascular disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure",
                                        "criterion": "congestive heart failure",
                                        "requirement": {
                                            "requirement_type": "control",
                                            "expected_value": false
                                        }
                                    },
                                    {
                                        "exact_snippets": "uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure",
                                        "criterion": "congestive heart failure",
                                        "requirement": {
                                            "requirement_type": "NYHA Class",
                                            "expected_value": {
                                                "comparisons": [
                                                    {
                                                        "operator": ">=",
                                                        "value": 3,
                                                        "unit": "NYHA Class"
                                                    }
                                                ]
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "uncontrolled angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "history of myocardial infarction",
                        "criterion": "myocardial infarction",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unstable angina",
                        "criterion": "angina",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "pulmonary embolism or stroke within 6 months prior to study entry",
                        "criterion": "pulmonary embolism or stroke",
                        "requirement": {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled hypertension",
                        "criterion": "hypertension",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "clinically significant arrhythmias not controlled by medication",
                                "criterion": "arrhythmias",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "clinically significant"
                                }
                            },
                            {
                                "exact_snippets": "clinically significant arrhythmias not controlled by medication",
                                "criterion": "arrhythmias",
                                "requirement": {
                                    "requirement_type": "control by medication",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled, clinically significant pulmonary disease",
                        "criterion": "pulmonary disease",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled, clinically significant pulmonary disease",
                        "criterion": "pulmonary disease",
                        "requirement": {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic obstructive pulmonary disease",
                        "criterion": "chronic obstructive pulmonary disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pulmonary hypertension",
                        "criterion": "pulmonary hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "uncontrolled, clinically significant pulmonary disease",
                                                "criterion": "pulmonary disease",
                                                "requirement": {
                                                    "requirement_type": "control",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "exact_snippets": "uncontrolled, clinically significant pulmonary disease",
                                                "criterion": "pulmonary disease",
                                                "requirement": {
                                                    "requirement_type": "clinical significance",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "chronic obstructive pulmonary disease",
                                                "criterion": "chronic obstructive pulmonary disease",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "pulmonary hypertension",
                                                "criterion": "pulmonary hypertension",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "uncontrolled, clinically significant pulmonary disease",
                        "criterion": "investigator opinion on risk",
                        "requirement": {
                            "requirement_type": "risk for pulmonary complications",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.",
                "criterions": [
                    {
                        "exact_snippets": "Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.",
                        "criterion": "metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.",
                                        "criterion": "metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.",
                                        "criterion": "metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.",
                                "criterion": "metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.",
                "criterions": [
                    {
                        "exact_snippets": "Has an active autoimmune disease",
                        "criterion": "active autoimmune disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "systemic treatment requirement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                        "criterion": "pneumonitis",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has an active autoimmune disease",
                                "criterion": "active autoimmune disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g., neomercazol, carbamazole) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g., in Graves' disease) is not considered a form of systemic treatment of an autoimmune disease.",
                                    "criterion": "systemic treatment of an autoimmune disease",
                                    "requirement": {
                                        "requirement_type": "type",
                                        "expected_value": "replacement therapy or thyroid hormone generation decrease"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                                "criterion": "pneumonitis",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                                "criterion": "pneumonitis",
                                "requirement": {
                                    "requirement_type": "systemic treatment requirement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years",
                                "criterion": "pneumonitis",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "past 2 years"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is currently receiving systemic steroid therapy at a prednisone equivalent dose of >10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.",
                "criterions": [
                    {
                        "exact_snippets": "currently receiving systemic steroid therapy",
                        "criterion": "systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prednisone equivalent dose of >10 mg daily",
                        "criterion": "prednisone equivalent dose",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least 1 week",
                        "criterion": "duration of systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    },
                    {
                        "exact_snippets": "other form of immunosuppressive therapy within 7 days prior to enrollment",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "other form of immunosuppressive therapy within 7 days prior to enrollment",
                        "criterion": "immunosuppressive therapy",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "currently receiving systemic steroid therapy",
                                                "criterion": "systemic steroid therapy",
                                                "requirement": {
                                                    "requirement_type": "presence",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "exact_snippets": "prednisone equivalent dose of >10 mg daily",
                                                "criterion": "prednisone equivalent dose",
                                                "requirement": {
                                                    "requirement_type": "dose",
                                                    "expected_value": {
                                                        "operator": ">",
                                                        "value": 10,
                                                        "unit": "mg"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "at least 1 week",
                                        "criterion": "duration of systemic steroid therapy",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 1,
                                                "unit": "week"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other form of immunosuppressive therapy within 7 days prior to enrollment",
                                "criterion": "immunosuppressive therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "other form of immunosuppressive therapy within 7 days prior to enrollment",
                                "criterion": "immunosuppressive therapy",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, uncontrolled infection",
                        "criterion": "uncontrolled infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... disseminated intravascular coagulation",
                        "criterion": "disseminated intravascular coagulation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, uncontrolled infection",
                                "criterion": "uncontrolled infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... disseminated intravascular coagulation",
                                "criterion": "disseminated intravascular coagulation",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.",
                "criterions": [
                    {
                        "exact_snippets": "Is at risk for disseminated BCG infection",
                        "criterion": "risk for disseminated BCG infection",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has previously demonstrated an allergic response to BCG or its components",
                        "criterion": "allergic response to BCG or its components",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Is at risk for disseminated BCG infection",
                        "criterion": "risk for disseminated BCG infection",
                        "requirement": {
                            "requirement_type": "risk",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has previously demonstrated an allergic response to BCG or its components",
                        "criterion": "allergic response to BCG or its components",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.",
                "criterions": [
                    {
                        "exact_snippets": "known positive status for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active or chronic Hepatitis (Hep) B or Hep C",
                        "criterion": "Hepatitis B or C status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "chronic"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known positive status for human immunodeficiency virus (HIV)",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "active or chronic Hepatitis (Hep) B or Hep C",
                        "criterion": "Hepatitis B or C status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "chronic"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.",
                "criterions": [
                    {
                        "exact_snippets": "any medical condition ... places the subject at an unacceptably high risk for toxicity",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "risk for toxicity",
                            "expected_value": "unacceptably high"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "any medical condition ... places the subject at an unacceptably high risk for toxicity",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "risk for toxicity",
                            "expected_value": "unacceptably high"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.",
                "criterions": [
                    {
                        "exact_snippets": "pT3b or pT4 tumors",
                        "criterion": "tumor stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "pT3b",
                                "pT4"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Gleason sum 7 (4+3)",
                        "criterion": "Gleason score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": "7 (4+3)"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "pT3b or pT4 tumors",
                                "criterion": "tumor stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "pT3b"
                                }
                            },
                            {
                                "exact_snippets": "pT3b or pT4 tumors",
                                "criterion": "tumor stage",
                                "requirement": {
                                    "requirement_type": "stage",
                                    "expected_value": "pT4"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Gleason sum 7 (4+3)",
                        "criterion": "Gleason score",
                        "requirement": {
                            "requirement_type": "score",
                            "expected_value": "7 (4+3)"
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}