{
    "info": {
        "nct_id": "NCT04812366",
        "official_title": "Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer",
        "inclusion_criteria": "- I. Males ≥ 18 years of age\n\nII. Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell differentiation at the time of initial diagnosis\n\nIII. High-risk localized prostate cancer as defined by:\n\n* PSA (prostate specific antigen) >20, any GS or >8 or\n* Gleason pattern 4 in 6 or more systematic cores (pattern 4 must be dominant, ≥50% average across 6 or more systematic cores) or\n* ≥ 50% Gleason pattern 4 in 3 or more systematic or Magnetic Resonance Imaging (MRI)-targeted cores and PSA ≥ 20 (may include G4+3 or G4+4 but pattern 4 must be dominant, ≥50% average across 3 or more systematic cores) or\n* ≥25% Gleason pattern 5 in 3 or more systematic or MRI-targeted cores (may include G4+5, or G3+5, but pattern 5 must be ≥25% average across 3 or more systematic cores).\n* Gleason > 8 or greater on minimum of one core either targeted or systematic biopsy and PSA >20\n* Participants with oligometastatic (< 3) metastases by PSMA (Prostate-Specific Membrane Antigen) imaging only who are deemed candidates for radical prostatectomy are eligible\n\nIV. Participants must consent to genetic testing at registration and prior to assignment by a central reference laboratory\n\nV. No prior systemic or localized treatment for prostate cancer. Up to 30 days of LHRHa is allowable prior to treatment.\n\nVI. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 (Appendix II) and a life expectancy of ≥ 3 years\n\nVII. Participants must have adequate end-organ function and all laboratory tests must be performed within 4 weeks prior to registration into master protocol.\n\nVIII. Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "- I. Received more than 30 days of LHRHa prior to registration and initiation of LHRHa + APA\n\nII. Stage T4 prostate cancer by clinical examination or radiologic evaluation\n\nIII. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution\n\nIV. Participants with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the participant to be managed according to the protocol. This includes but is not limited to:\n\n* Active infection or chronic liver disease requiring systemic therapy;\n* Active or known human immunodeficiency virus (HIV) with detectable viral load;\n* Uncontrolled or recent clinically significant cardiac disease, including: angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months; history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy; history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;\n* Participants with uncontrolled hypertension\n\nV. Participants who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n\nVI. Participants with a history of hypersensitivity to any of the study drugs or any excipient\n\nVII. Participants with a history of non-compliance to medical regimen\n\nVIII. Severe concurrent disease, infection, or co-morbidity that, in the judgement of the Investigator, would make the participant inappropriate for enrollment or prostatectomy\n\nIX. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer\n\nX. Receiving concurrent androgens, estrogens, or pregestational agents, or prior exposure to any of these agents within 6 months prior to randomization\n\nXI. M1 by conventional imaging (CT, bone scan)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "- I. Males ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Males",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "II. Histologically confirmed adenocarcinoma of the prostate without pathologic evidence of small cell differentiation at the time of initial diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "without pathologic evidence of small cell differentiation",
                    "criterion": "small cell differentiation",
                    "requirements": [
                        {
                            "requirement_type": "pathologic evidence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "at the time of initial diagnosis",
                    "criterion": "initial diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at the time of initial diagnosis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "III. High-risk localized prostate cancer as defined by:",
            "criterions": [
                {
                    "exact_snippets": "High-risk localized prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high-risk"
                        },
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA (prostate specific antigen) >20, any GS or >8 or",
            "criterions": [
                {
                    "exact_snippets": "PSA (prostate specific antigen) >20",
                    "criterion": "PSA (prostate specific antigen)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any GS",
                    "criterion": "Gleason score (GS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "GS ... >8",
                    "criterion": "Gleason score (GS)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason pattern 4 in 6 or more systematic cores (pattern 4 must be dominant, ≥50% average across 6 or more systematic cores) or",
            "criterions": [
                {
                    "exact_snippets": "Gleason pattern 4 in 6 or more systematic cores",
                    "criterion": "Gleason pattern 4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "systematic cores"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pattern 4 must be dominant, ≥50% average across 6 or more systematic cores",
                    "criterion": "dominance of pattern 4",
                    "requirements": [
                        {
                            "requirement_type": "dominance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "average percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥ 50% Gleason pattern 4 in 3 or more systematic or Magnetic Resonance Imaging (MRI)-targeted cores and PSA ≥ 20 (may include G4+3 or G4+4 but pattern 4 must be dominant, ≥50% average across 3 or more systematic cores) or",
            "criterions": [
                {
                    "exact_snippets": "≥ 50% Gleason pattern 4 in 3 or more systematic or Magnetic Resonance Imaging (MRI)-targeted cores",
                    "criterion": "Gleason pattern 4",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "core count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cores"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA ≥ 20",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ≥25% Gleason pattern 5 in 3 or more systematic or MRI-targeted cores (may include G4+5, or G3+5, but pattern 5 must be ≥25% average across 3 or more systematic cores).",
            "criterions": [
                {
                    "exact_snippets": "≥25% Gleason pattern 5 in 3 or more systematic or MRI-targeted cores",
                    "criterion": "Gleason pattern 5",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "core count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cores"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pattern 5 must be ≥25% average across 3 or more systematic cores",
                    "criterion": "Gleason pattern 5",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "core count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cores"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason > 8 or greater on minimum of one core either targeted or systematic biopsy and PSA >20",
            "criterions": [
                {
                    "exact_snippets": "Gleason > 8",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA >20",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with oligometastatic (< 3) metastases by PSMA (Prostate-Specific Membrane Antigen) imaging only who are deemed candidates for radical prostatectomy are eligible",
            "criterions": [
                {
                    "exact_snippets": "oligometastatic (< 3) metastases",
                    "criterion": "oligometastatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSMA (Prostate-Specific Membrane Antigen) imaging",
                    "criterion": "PSMA imaging",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "PSMA imaging"
                        }
                    ]
                },
                {
                    "exact_snippets": "deemed candidates for radical prostatectomy",
                    "criterion": "candidacy for radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "IV. Participants must consent to genetic testing at registration and prior to assignment by a central reference laboratory",
            "criterions": [
                {
                    "exact_snippets": "Participants must consent to genetic testing",
                    "criterion": "genetic testing consent",
                    "requirements": [
                        {
                            "requirement_type": "consent",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to assignment by a central reference laboratory",
                    "criterion": "assignment by a central reference laboratory",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "V. No prior systemic or localized treatment for prostate cancer. Up to 30 days of LHRHa is allowable prior to treatment.",
            "criterions": [
                {
                    "exact_snippets": "No prior systemic or localized treatment for prostate cancer",
                    "criterion": "prior treatment for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Up to 30 days of LHRHa is allowable prior to treatment",
                    "criterion": "LHRHa treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "VI. ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 (Appendix II) and a life expectancy of ≥ 3 years",
            "criterions": [
                {
                    "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of ≥ 3 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "VII. Participants must have adequate end-organ function and all laboratory tests must be performed within 4 weeks prior to registration into master protocol.",
            "criterions": [
                {
                    "exact_snippets": "adequate end-organ function",
                    "criterion": "end-organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "all laboratory tests must be performed within 4 weeks prior to registration",
                    "criterion": "laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "VIII. Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrolment in the trial to document their willingness to participate.",
            "criterions": [
                {
                    "exact_snippets": "Participant consent must be appropriately obtained",
                    "criterion": "participant consent",
                    "requirements": [
                        {
                            "requirement_type": "appropriateness",
                            "expected_value": "in accordance with applicable local and regulatory requirements"
                        }
                    ]
                },
                {
                    "exact_snippets": "Each participant must sign a consent form",
                    "criterion": "consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to enrolment in the trial",
                    "criterion": "consent form",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to enrolment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "- I. Received more than 30 days of LHRHa prior to registration and initiation of LHRHa + APA",
            "criterions": [
                {
                    "exact_snippets": "Received more than 30 days of LHRHa",
                    "criterion": "LHRHa treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "II. Stage T4 prostate cancer by clinical examination or radiologic evaluation",
            "criterions": [
                {
                    "exact_snippets": "Stage T4 prostate cancer",
                    "criterion": "prostate cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T4"
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical examination or radiologic evaluation",
                    "criterion": "method of evaluation",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "clinical examination",
                                "radiologic evaluation"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "III. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone more than 50 ng/dL below the normal range for the institution",
            "criterions": [
                {
                    "exact_snippets": "Hypogonadism or severe androgen deficiency",
                    "criterion": "hypogonadism or severe androgen deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "screening serum testosterone more than 50 ng/dL below the normal range",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL below normal range"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "IV. Participants with serious illnesses or medical conditions which could cause unacceptable safety risks or would not permit the participant to be managed according to the protocol. This includes but is not limited to:",
            "criterions": [
                {
                    "exact_snippets": "serious illnesses or medical conditions",
                    "criterion": "serious illnesses or medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "safety risk",
                            "expected_value": "unacceptable"
                        },
                        {
                            "requirement_type": "protocol management",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection or chronic liver disease requiring systemic therapy;",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic liver disease requiring systemic therapy",
                    "criterion": "chronic liver disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or known human immunodeficiency virus (HIV) with detectable viral load;",
            "criterions": [
                {
                    "exact_snippets": "Active or known human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "known"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable viral load",
                    "criterion": "HIV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled or recent clinically significant cardiac disease, including: angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months; history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy; history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: ... symptomatic pericarditis",
                    "criterion": "symptomatic pericarditis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: ... coronary artery bypass grafting",
                    "criterion": "coronary artery bypass grafting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: ... coronary angioplasty",
                    "criterion": "coronary angioplasty",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: ... stenting",
                    "criterion": "stenting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled or recent clinically significant cardiac disease, including: ... myocardial infarction in the previous 12 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of documented congestive heart failure (New York Heart Association functional classification III-IV)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "New York Heart Association functional classification III-IV"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... cardiomyopathy",
                    "criterion": "cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of any cardiac arrhythmias, e.g. ventricular, supraventricular, nodal arrhythmias",
                    "criterion": "cardiac arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of any ... conduction abnormality in the previous 12 months",
                    "criterion": "conduction abnormality",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "V. Participants who are unable to swallow oral medication and/or have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)",
            "criterions": [
                {
                    "exact_snippets": "unable to swallow oral medication",
                    "criterion": "ability to swallow oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "impairment of gastrointestinal (GI) function or GI disease",
                    "criterion": "gastrointestinal (GI) function or disease",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative diseases",
                    "criterion": "ulcerative diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled nausea",
                    "criterion": "nausea",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "vomiting",
                    "criterion": "vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "malabsorption syndrome",
                    "criterion": "malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small bowel resection",
                    "criterion": "small bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "VI. Participants with a history of hypersensitivity to any of the study drugs or any excipient",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity to any of the study drugs",
                    "criterion": "hypersensitivity to study drugs",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hypersensitivity to ... any excipient",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "VII. Participants with a history of non-compliance to medical regimen",
            "criterions": [
                {
                    "exact_snippets": "history of non-compliance to medical regimen",
                    "criterion": "non-compliance to medical regimen",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "VIII. Severe concurrent disease, infection, or co-morbidity that, in the judgement of the Investigator, would make the participant inappropriate for enrollment or prostatectomy",
            "criterions": [
                {
                    "exact_snippets": "Severe concurrent disease",
                    "criterion": "concurrent disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe concurrent ... infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe concurrent ... co-morbidity",
                    "criterion": "co-morbidity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "IX. Prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior androgen deprivation",
                    "criterion": "androgen deprivation",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... radiation",
                    "criterion": "radiation",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "X. Receiving concurrent androgens, estrogens, or pregestational agents, or prior exposure to any of these agents within 6 months prior to randomization",
            "criterions": [
                {
                    "exact_snippets": "Receiving concurrent androgens",
                    "criterion": "androgens",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving concurrent ... estrogens",
                    "criterion": "estrogens",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Receiving concurrent ... pregestational agents",
                    "criterion": "pregestational agents",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior exposure to any of these agents within 6 months prior to randomization",
                    "criterion": "prior exposure to androgens, estrogens, or pregestational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last exposure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "XI. M1 by conventional imaging (CT, bone scan)",
            "criterions": [
                {
                    "exact_snippets": "M1 by conventional imaging (CT, bone scan)",
                    "criterion": "M1 stage",
                    "requirements": [
                        {
                            "requirement_type": "detection method",
                            "expected_value": [
                                "CT",
                                "bone scan"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}