{
    "info": {
        "nct_id": "NCT04907227",
        "official_title": "A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)",
        "inclusion_criteria": "* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening\n* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)\n* Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug\n* Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)\n* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization\n* Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)\n* Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex\n* Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications\n* Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules\n* Has an active infection (including tuberculosis) requiring systemic therapy\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients\n* Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)\n* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs\n* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization\n* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer\n* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)\n* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC\n* Has hypersensitivity to docetaxel or polysorbate 80\n* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study\n* Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent\n* Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis\n* Has received a live vaccine within 30 days prior to randomization\n* Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization\n* Has received prior treatment with ketoconazole for prostate cancer\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n* Has a \"superscan\" bone scan\n* Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment\n* Has had an allogenic tissue/solid organ transplant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology",
                "criterions": [
                    {
                        "exact_snippets": "histologically- or cytologically-confirmed adenocarcinoma of the prostate",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "without small cell histology",
                        "criterion": "small cell histology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "histologically- or cytologically-confirmed adenocarcinoma of the prostate",
                        "criterion": "adenocarcinoma of the prostate",
                        "requirement": {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "without small cell histology",
                        "criterion": "small cell histology",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)",
                "criterions": [
                    {
                        "exact_snippets": "current evidence of metastatic disease",
                        "criterion": "metastatic disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "bone lesions on bone scan",
                        "criterion": "bone lesions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)",
                        "criterion": "soft tissue disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "current evidence of metastatic disease",
                                "criterion": "metastatic disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "bone lesions on bone scan",
                                "criterion": "bone lesions",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "current evidence of metastatic disease",
                                "criterion": "metastatic disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)",
                                "criterion": "soft tissue disease",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide)",
                        "criterion": "prior treatment with NHA",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "NHA"
                            }
                        }
                    },
                    {
                        "exact_snippets": "for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC)",
                        "criterion": "prostate cancer type",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "metastatic hormone-sensitive prostate cancer (mHSPC)",
                                "castration-resistant prostate cancer (CRPC)"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "progressed through treatment",
                        "criterion": "treatment progression",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has become intolerant of the drug",
                        "criterion": "drug intolerance",
                        "requirement": {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide)",
                                        "criterion": "prior treatment with NHA",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": "=",
                                                "value": 1,
                                                "unit": "NHA"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC)",
                                        "criterion": "prostate cancer type",
                                        "requirement": {
                                            "requirement_type": "type",
                                            "expected_value": [
                                                "metastatic hormone-sensitive prostate cancer (mHSPC)",
                                                "castration-resistant prostate cancer (CRPC)"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "progressed through treatment",
                                        "criterion": "treatment progression",
                                        "requirement": {
                                            "requirement_type": "progression",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "has become intolerant of the drug",
                                        "criterion": "drug intolerance",
                                        "requirement": {
                                            "requirement_type": "intolerance",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)",
                "criterions": [
                    {
                        "exact_snippets": "ongoing androgen deprivation",
                        "criterion": "androgen deprivation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serum testosterone <50 ng/dL (<2.0 nM)",
                        "criterion": "serum testosterone",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "ng/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 2.0,
                                        "unit": "nM"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ongoing androgen deprivation",
                        "criterion": "androgen deprivation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "serum testosterone <50 ng/dL (<2.0 nM)",
                        "criterion": "serum testosterone",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "ng/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 2.0,
                                        "unit": "nM"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab)",
                        "criterion": "bone resorptive therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "must have been on stable doses prior to randomization",
                        "criterion": "stable doses of bone resorptive therapy",
                        "requirement": {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab)",
                    "criterion": "bone resorptive therapy",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                },
                "then_criteria": {
                    "exact_snippets": "must have been on stable doses prior to randomization",
                    "criterion": "stable doses of bone resorptive therapy",
                    "requirement": {
                        "requirement_type": "stability",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "Must be MALE",
                "criterions": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "MALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years",
                "criterions": [
                    {
                        "exact_snippets": "Has a known additional malignancy",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has a known additional malignancy",
                        "criterion": "additional malignancy",
                        "requirement": {
                            "requirement_type": "active treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has a known additional malignancy",
                                "criterion": "additional malignancy",
                                "requirement": {
                                    "requirement_type": "progression",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Has a known additional malignancy",
                                "criterion": "additional malignancy",
                                "requirement": {
                                    "requirement_type": "active treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has an active autoimmune disease that has required systemic treatment in past 2 years",
                "criterions": [
                    {
                        "exact_snippets": "Has an active autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "autoimmune disease that has required systemic treatment in past 2 years",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "past 2 years"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has an active autoimmune disease",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    },
                    {
                        "exact_snippets": "autoimmune disease that has required systemic treatment in past 2 years",
                        "criterion": "systemic treatment for autoimmune disease",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": "past 2 years"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy",
                "criterions": [
                    {
                        "exact_snippets": "Has a diagnosis of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "is receiving chronic systemic steroid therapy",
                        "criterion": "chronic systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has a diagnosis of immunodeficiency",
                        "criterion": "immunodeficiency",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "is receiving chronic systemic steroid therapy",
                        "criterion": "chronic systemic steroid therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications",
                "criterions": [
                    {
                        "exact_snippets": "Has undergone major surgery",
                        "criterion": "major surgery",
                        "requirement": {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "local prostate intervention (excluding prostate biopsy)",
                        "criterion": "local prostate intervention",
                        "requirement": {
                            "requirement_type": "time since intervention",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "not recovered adequately from the toxicities and/or complications",
                        "criterion": "recovery from surgery or intervention",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has undergone major surgery",
                                        "criterion": "major surgery",
                                        "requirement": {
                                            "requirement_type": "time since surgery",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 28,
                                                "unit": "days"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "not recovered adequately from the toxicities and/or complications",
                                        "criterion": "recovery from surgery or intervention",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "local prostate intervention (excluding prostate biopsy)",
                                        "criterion": "local prostate intervention",
                                        "requirement": {
                                            "requirement_type": "time since intervention",
                                            "expected_value": {
                                                "operator": "<",
                                                "value": 28,
                                                "unit": "days"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "not recovered adequately from the toxicities and/or complications",
                                        "criterion": "recovery from surgery or intervention",
                                        "requirement": {
                                            "requirement_type": "recovery status",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules",
                "criterions": [
                    {
                        "exact_snippets": "gastrointestinal disorder affecting absorption",
                        "criterion": "gastrointestinal disorder",
                        "requirement": {
                            "requirement_type": "affecting absorption",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unable to swallow tablets/capsules",
                        "criterion": "ability to swallow tablets/capsules",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "gastrointestinal disorder affecting absorption",
                        "criterion": "gastrointestinal disorder",
                        "requirement": {
                            "requirement_type": "affecting absorption",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unable to swallow tablets/capsules",
                        "criterion": "ability to swallow tablets/capsules",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has an active infection (including tuberculosis) requiring systemic therapy",
                "criterions": [
                    {
                        "exact_snippets": "Has an active infection (including tuberculosis)",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring systemic therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has an active infection (including tuberculosis)",
                        "criterion": "active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "requiring systemic therapy",
                        "criterion": "systemic therapy",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis",
                "criterions": [
                    {
                        "exact_snippets": "Has a history of (non-infectious) pneumonitis",
                        "criterion": "history of non-infectious pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "pneumonitis that required steroids",
                        "criterion": "pneumonitis requiring steroids",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "current pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has a history of (non-infectious) pneumonitis",
                                "criterion": "history of non-infectious pneumonitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "pneumonitis that required steroids",
                                "criterion": "pneumonitis requiring steroids",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "current pneumonitis",
                        "criterion": "current pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection",
                "criterions": [
                    {
                        "exact_snippets": "Has known active human immunodeficiency virus (HIV) ... infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... hepatitis B virus (HBV) ... infection",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... hepatitis C virus (HCV) infection",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has known active human immunodeficiency virus (HIV) ... infection",
                        "criterion": "HIV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... hepatitis B virus (HBV) ... infection",
                        "criterion": "HBV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has known active ... hepatitis C virus (HCV) infection",
                        "criterion": "HCV infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis",
                "criterions": [
                    {
                        "exact_snippets": "known active central nervous system (CNS) metastases",
                        "criterion": "central nervous system (CNS) metastases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "carcinomatous meningitis",
                        "criterion": "carcinomatous meningitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "known active central nervous system (CNS) metastases",
                                "criterion": "central nervous system (CNS) metastases",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "carcinomatous meningitis",
                                "criterion": "carcinomatous meningitis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)",
                "criterions": [
                    {
                        "exact_snippets": "Has symptomatic congestive heart failure",
                        "criterion": "congestive heart failure",
                        "requirement": {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "New York Heart Association Class III or IV heart disease",
                        "criterion": "New York Heart Association heart disease classification",
                        "requirement": {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Class III",
                                "Class IV"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has symptomatic congestive heart failure",
                                "criterion": "congestive heart failure",
                                "requirement": {
                                    "requirement_type": "symptomatic",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "New York Heart Association Class III or IV heart disease",
                                "criterion": "New York Heart Association heart disease classification",
                                "requirement": {
                                    "requirement_type": "classification",
                                    "expected_value": [
                                        "Class III",
                                        "Class IV"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs",
                "criterions": [
                    {
                        "exact_snippets": "Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization",
                        "criterion": "prior anti-cancer monoclonal antibody (mAb)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs",
                        "criterion": "recovery from AEs due to mAbs",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization",
                        "criterion": "prior anti-cancer monoclonal antibody (mAb)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs",
                            "criterion": "recovery from AEs due to mAbs",
                            "requirement": {
                                "requirement_type": "severity",
                                "expected_value": {
                                    "operator": "<=",
                                    "value": 1,
                                    "unit": "Grade"
                                }
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Has used herbal products that may have hormonal anti-prostate cancer activity",
                        "criterion": "use of herbal products with hormonal anti-prostate cancer activity",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has used herbal products that ... are known to decrease PSA levels",
                        "criterion": "use of herbal products known to decrease PSA levels",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has used herbal products that may have hormonal anti-prostate cancer activity",
                                "criterion": "use of herbal products with hormonal anti-prostate cancer activity",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has used herbal products that ... are known to decrease PSA levels",
                                "criterion": "use of herbal products known to decrease PSA levels",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior treatment with radium or other therapeutic radiopharmaceuticals",
                        "criterion": "prior treatment with radium or other therapeutic radiopharmaceuticals",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Has received prior treatment with radium or other therapeutic radiopharmaceuticals",
                                "criterion": "prior treatment with radium or other therapeutic radiopharmaceuticals",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "prostate cancer",
                        "criterion": "prostate cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1)",
                        "criterion": "prior therapy with anti-PD-1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... anti-programmed cell death-ligand 1 (anti-PD-L1)",
                        "criterion": "prior therapy with anti-PD-L1",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... anti PD-L2 agent",
                        "criterion": "prior therapy with anti-PD-L2",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... agent directed to another stimulatory or co-inhibitory T-cell receptor",
                        "criterion": "prior therapy with agent directed to another T-cell receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]",
                        "criterion": "prior therapy with CTLA-4",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... OX-40",
                        "criterion": "prior therapy with OX-40",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received prior therapy with ... CD137",
                        "criterion": "prior therapy with CD137",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1)",
                                "criterion": "prior therapy with anti-PD-1",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... anti-programmed cell death-ligand 1 (anti-PD-L1)",
                                "criterion": "prior therapy with anti-PD-L1",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... anti PD-L2 agent",
                                "criterion": "prior therapy with anti-PD-L2",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... agent directed to another stimulatory or co-inhibitory T-cell receptor",
                                "criterion": "prior therapy with agent directed to another T-cell receptor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]",
                                "criterion": "prior therapy with CTLA-4",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... OX-40",
                                "criterion": "prior therapy with OX-40",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior therapy with ... CD137",
                                "criterion": "prior therapy with CD137",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has hypersensitivity to docetaxel or polysorbate 80",
                "criterions": [
                    {
                        "exact_snippets": "hypersensitivity to docetaxel",
                        "criterion": "hypersensitivity to docetaxel",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... polysorbate 80",
                        "criterion": "hypersensitivity to polysorbate 80",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "hypersensitivity to docetaxel",
                        "criterion": "hypersensitivity to docetaxel",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hypersensitivity to ... polysorbate 80",
                        "criterion": "hypersensitivity to polysorbate 80",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "therapy type",
                            "expected_value": [
                                "targeted small molecule therapy",
                                "abiraterone acetate",
                                "enzalutamide",
                                "apalutamide",
                                "darolutamide"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment",
                        "criterion": "prior therapy",
                        "requirement": {
                            "requirement_type": "time since therapy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "Grade ≤1 or at baseline"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment",
                                        "criterion": "prior therapy",
                                        "requirement": {
                                            "requirement_type": "therapy type",
                                            "expected_value": [
                                                "targeted small molecule therapy",
                                                "abiraterone acetate",
                                                "enzalutamide",
                                                "apalutamide",
                                                "darolutamide"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment",
                                        "criterion": "prior therapy",
                                        "requirement": {
                                            "requirement_type": "time since therapy",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": "Grade ≤1 or at baseline"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior radiotherapy to within 2 weeks of start of study treatment",
                        "criterion": "prior radiotherapy",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Participants must have recovered from all radiation-related toxicities",
                        "criterion": "radiation-related toxicities",
                        "requirement": {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not require corticosteroids",
                        "criterion": "corticosteroid requirement",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "not have had radiation pneumonitis",
                        "criterion": "radiation pneumonitis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Has received prior radiotherapy to within 2 weeks of start of study treatment",
                                "criterion": "prior radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "Participants must have recovered from all radiation-related toxicities",
                                    "criterion": "radiation-related toxicities",
                                    "requirement": {
                                        "requirement_type": "recovery",
                                        "expected_value": true
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "not require corticosteroids",
                            "criterion": "corticosteroid requirement",
                            "requirement": {
                                "requirement_type": "requirement",
                                "expected_value": false
                            }
                        }
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "not have had radiation pneumonitis",
                            "criterion": "radiation pneumonitis",
                            "requirement": {
                                "requirement_type": "presence",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received a live vaccine within 30 days prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Has received a live vaccine within 30 days prior to randomization",
                        "criterion": "live vaccine",
                        "requirement": {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Has received a live vaccine within 30 days prior to randomization",
                    "criterion": "live vaccine",
                    "requirement": {
                        "requirement_type": "time since administration",
                        "expected_value": {
                            "operator": "<=",
                            "value": 30,
                            "unit": "days"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization",
                "criterions": [
                    {
                        "exact_snippets": "Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride)",
                        "criterion": "treatment with 5α reductase inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received treatment with ... estrogens",
                        "criterion": "treatment with estrogens",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Has received treatment with ... cyproterone",
                        "criterion": "treatment with cyproterone",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "within 4 weeks prior to randomization",
                        "criterion": "time since treatment",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride)",
                                        "criterion": "treatment with 5α reductase inhibitors",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "within 4 weeks prior to randomization",
                                        "criterion": "time since treatment",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has received treatment with ... estrogens",
                                        "criterion": "treatment with estrogens",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "within 4 weeks prior to randomization",
                                        "criterion": "time since treatment",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Has received treatment with ... cyproterone",
                                        "criterion": "treatment with cyproterone",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "within 4 weeks prior to randomization",
                                        "criterion": "time since treatment",
                                        "requirement": {
                                            "requirement_type": "duration",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 4,
                                                "unit": "weeks"
                                            }
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior treatment with ketoconazole for prostate cancer",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior treatment with ketoconazole for prostate cancer",
                        "criterion": "prior treatment with ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has received prior treatment with ketoconazole for prostate cancer",
                        "criterion": "prior treatment with ketoconazole",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has a \"superscan\" bone scan",
                "criterions": [
                    {
                        "exact_snippets": "\"superscan\" bone scan",
                        "criterion": "superscan bone scan",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "\"superscan\" bone scan",
                    "criterion": "superscan bone scan",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Is expecting to conceive or father children within the projected duration of the study",
                        "criterion": "expectation to conceive or father children",
                        "requirement": {
                            "requirement_type": "expectation",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Is expecting to conceive or father children within the projected duration of the study",
                    "criterion": "expectation to conceive or father children",
                    "requirement": {
                        "requirement_type": "expectation",
                        "expected_value": false
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has had an allogenic tissue/solid organ transplant",
                "criterions": [
                    {
                        "exact_snippets": "Has had an allogenic tissue/solid organ transplant",
                        "criterion": "allogenic tissue/solid organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Has had an allogenic tissue/solid organ transplant",
                        "criterion": "allogenic tissue/solid organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening",
                "criterions": [
                    {
                        "exact_snippets": "prostate cancer progression",
                        "criterion": "prostate cancer progression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "on androgen deprivation therapy (or post bilateral orchiectomy)",
                        "criterion": "androgen deprivation therapy or bilateral orchiectomy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "on or post"
                        }
                    },
                    {
                        "exact_snippets": "within 6 months prior to screening",
                        "criterion": "time since progression",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "prostate cancer progression",
                                "criterion": "prostate cancer progression",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "within 6 months prior to screening",
                                "criterion": "time since progression",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "months"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)",
                "criterions": [
                    {
                        "exact_snippets": "Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm",
                        "criterion": "sperm donation",
                        "requirement": {
                            "requirement_type": "refrain",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): ... Use contraception unless confirmed to be azoospermic",
                        "criterion": "contraception use",
                        "requirement": {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unless confirmed to be azoospermic (vasectomized or secondary to medical cause)",
                        "criterion": "azoospermia",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex",
                "criterions": [
                    {
                        "exact_snippets": "Participants must agree to use male condom",
                        "criterion": "use of male condom",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample",
                "criterions": [
                    {
                        "exact_snippets": "newly obtained core or excisional biopsy (obtained within 12 months of screening)",
                        "criterion": "biopsy",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "core",
                                "excisional"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "newly obtained core or excisional biopsy (obtained within 12 months of screening)",
                        "criterion": "biopsy",
                        "requirement": {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "soft tissue not previously irradiated",
                        "criterion": "soft tissue",
                        "requirement": {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "samples from tumors progressing in a prior site of radiation are allowed",
                        "criterion": "tumor progression",
                        "requirement": {
                            "requirement_type": "site of radiation",
                            "expected_value": "prior"
                        }
                    },
                    {
                        "exact_snippets": "Participants with bone only or bone predominant disease may provide a bone biopsy sample",
                        "criterion": "bone disease",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": [
                                "bone only",
                                "bone predominant"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Participants with bone only or bone predominant disease may provide a bone biopsy sample",
                        "criterion": "bone disease",
                        "requirement": {
                            "requirement_type": "sample type",
                            "expected_value": "bone biopsy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization",
                "criterions": [
                    {
                        "exact_snippets": "Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "assessed within 7 days of randomization",
                        "criterion": "ECOG performance status assessment timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days of randomization"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "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": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients",
                "criterions": [
                    {
                        "exact_snippets": "severe hypersensitivity (≥Grade 3) to pembrolizumab",
                        "criterion": "hypersensitivity to pembrolizumab",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "severe hypersensitivity (≥Grade 3) to ... any of its excipients",
                        "criterion": "hypersensitivity to pembrolizumab excipients",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe hypersensitivity (Grade 3) to pembrolizumab",
                                "criterion": "hypersensitivity to pembrolizumab",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "severe hypersensitivity (Grade 3) to ... any of its excipients",
                                "criterion": "hypersensitivity to pembrolizumab excipients",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC",
                "criterions": [
                    {
                        "exact_snippets": "Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC",
                        "criterion": "prior treatment with docetaxel or another chemotherapy agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC",
                                "criterion": "prior treatment with docetaxel",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC",
                                "criterion": "prior treatment with another chemotherapy agent for mCRPC",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study",
                "criterions": [
                    {
                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                        "requirement": {
                            "requirement_type": "strength",
                            "expected_value": [
                                "strong",
                                "moderate"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                        "requirement": {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "cannot be discontinued for the duration of the study",
                        "criterion": "discontinuation of inhibitors",
                        "requirement": {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                                        "requirement": {
                                            "requirement_type": "strength",
                                            "expected_value": "strong"
                                        }
                                    },
                                    {
                                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                                        "requirement": {
                                            "requirement_type": "current use",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                                        "requirement": {
                                            "requirement_type": "strength",
                                            "expected_value": "moderate"
                                        }
                                    },
                                    {
                                        "exact_snippets": "currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4",
                                        "criterion": "inhibitors of cytochrome P450 (CYP)3A4",
                                        "requirement": {
                                            "requirement_type": "current use",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "cannot be discontinued for the duration of the study",
                        "criterion": "discontinuation of inhibitors",
                        "requirement": {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment",
                "criterions": [
                    {
                        "exact_snippets": "Is currently participating in or has participated in a study of an investigational agent",
                        "criterion": "participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "has used an investigational device within 4 weeks prior to the first dose of study treatment",
                        "criterion": "use of an investigational device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Is currently participating in or has participated in a study of an investigational agent",
                        "criterion": "participation in a study of an investigational agent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "has used an investigational device within 4 weeks prior to the first dose of study treatment",
                        "criterion": "use of an investigational device",
                        "requirement": {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}