{
    "info": {
        "nct_id": "NCT05498272",
        "official_title": "A Phase 2 Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations (NePtune)",
        "inclusion_criteria": "Subject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration.\n* Age ≥ 18 years at the time of consent.\n* T stage 1-3 prostatic adenocarcinoma per AJCC staging manual Ed8.\n* Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample. Patients with intraductal carcinoma are eligible.\n* Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within 7 months from registration. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on magnetic resonance imaging (MRI).\n* Localized unfavorable intermediate or high-risk prostate cancer patients. Patients must have at least one of the following features:\n\n  * Gleason ≥ 4+3 (grade group 3, 4, 5) OR\n  * PSA > 20 ng/dL OR\n  * T3 disease NOTE: Patients with intraductal carcinoma are eligible independent of Gleason score, PSA and T stage.\n* Must have evidence of germline or somatic BRCA1/2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 gene alteration via standard of care CLIA based assay detection. Testing will be confirmed centrally but results of central testing not required for enrollment.\n* No evidence of metastatic disease as determined by radionuclide bone scan and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis.\n* Participants must be candidates for RP and considered surgically resectable by urologic evaluation.\n* ECOG Performance Status of 0-1 within 28 days prior to registration.\n* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.\n\n  * White blood cell count ≥ 3,000/mcL\n  * Absolute neutrophil count ≥ 1,500/mcL\n  * Hemoglobin ≥ 10 g/dL with no transfusion support in the past 28 days\n  * Platelets ≥ 100,000/mcL\n  * Aspartate aminotransferase, alanine aminotransferase ≤ 2.5×ULN, and total bilirubin ≤ 1.5 x Institutional upper limit of normal\n  * Calculated creatinine clearance ≥ 51 mL/min based on Cockcroft-Gault formula or 24 hour urine. NOTE: See the protocol for Cockcroft-Gault formula or 24 hour urine.\n* Life expectancy≥ 16 weeks.\n* Subjects must use a condom plus spermicide beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. See protocol for additional details.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "Subjects meeting any of the criteria below may not participate in the study:\n\n* Active infection requiring systemic therapy.\n* Prior treatments not allowed: hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens and radiation therapy. Prior bicalutamide is allowed if taken for < 4 weeks prior to registration and there is a washout period of 2 weeks prior to the initiation of study treatment. LHRH agonist/antagonist therapy is allowed if begun within 4 weeks of registration. Prior 5-alpha reductase inhibitors are allowed but require a washout period of 2 weeks to initiation of study treatment.\n* Prior treatment with a PARP inhibitor.\n* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:\n\n  * tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice).\n  * Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at screening. Testing is not required unless there was a prior known positive hepatitis B or C test or hepatitis is suspected at screening. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Known to have tested positive for human immunodeficiency virus (HIV) unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n* Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular steroids or inhaled corticosteroids are permitted.\n* Active cardiac disease, defined as:\n\n  * Myocardial infarction within 6 months of study treatment.\n  * Uncontrolled angina within 3 months of study treatment.\n  * Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless an echocardiogram performed within 3 months of the screening visit results in a left ventricular ejection fraction that is ≥ 45%.\n  * History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)\n  * Other clinically significant cardiovascular disease within 6 months of registration.\n* Uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n* Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans.\n* Major surgery within 4 weeks from start of treatment. Subjects must have recovered from any effects as the surgery as assessed by investigator discretion.\n* Treatment with any investigational drug within 28 days prior to registration.\n* Persistent toxicities Grade > 2 caused by previous cancer therapy (per Common Terminology Criteria for Adverse Event (CTCAE)).\n* Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.\n* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorders that prohibits obtaining informed consent.\n* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.\n* Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.\n* Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n* Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to the protocol).\n* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Written informed consent and HIPAA authorization for release of personal health information prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HIPAA authorization for release of personal health information",
                    "criterion": "HIPAA authorization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years at the time of consent.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T stage 1-3 prostatic adenocarcinoma per AJCC staging manual Ed8.",
            "criterions": [
                {
                    "exact_snippets": "T stage 1-3 prostatic adenocarcinoma",
                    "criterion": "T stage of prostatic adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "per AJCC staging manual Ed8",
                    "criterion": "AJCC staging manual edition",
                    "requirements": [
                        {
                            "requirement_type": "edition",
                            "expected_value": "8"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample. Patients with intraductal carcinoma are eligible.",
            "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 histological variants comprising >50% of the sample",
                    "criterion": "histological variants",
                    "requirements": [
                        {
                            "requirement_type": "composition",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "% of the sample"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with intraductal carcinoma are eligible",
                    "criterion": "intraductal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within 7 months from registration. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on magnetic resonance imaging (MRI).",
            "criterions": [
                {
                    "exact_snippets": "3 core biopsies involved with cancer",
                    "criterion": "core biopsies involved with cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "core biopsies"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "a minimum of 6 core biopsies must be obtained",
                    "criterion": "core biopsies obtained",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "core biopsies"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prostate biopsy must be within 7 months from registration",
                    "criterion": "prostate biopsy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 months from registration"
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 3 core biopsies are allowed if the patient has >1 cm ... on magnetic resonance imaging (MRI)",
                    "criterion": "lesion size on MRI",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Less than 3 core biopsies are allowed if the patient has ... T3 disease on magnetic resonance imaging (MRI)",
                    "criterion": "T3 disease on MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Localized unfavorable intermediate or high-risk prostate cancer patients. Patients must have at least one of the following features:",
            "criterions": [
                {
                    "exact_snippets": "Localized unfavorable intermediate or high-risk prostate cancer",
                    "criterion": "prostate cancer risk",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": [
                                "unfavorable intermediate",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Localized unfavorable intermediate or high-risk prostate cancer",
                    "criterion": "prostate cancer localization",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason ≥ 4+3 (grade group 3, 4, 5) OR",
            "criterions": [
                {
                    "exact_snippets": "Gleason ≥ 4+3 (grade group 3, 4, 5)",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4.3,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "grade group",
                            "expected_value": [
                                "3",
                                "4",
                                "5"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA > 20 ng/dL OR",
            "criterions": [
                {
                    "exact_snippets": "PSA > 20 ng/dL",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T3 disease NOTE: Patients with intraductal carcinoma are eligible independent of Gleason score, PSA and T stage.",
            "criterions": [
                {
                    "exact_snippets": "T3 disease",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "T3"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with intraductal carcinoma are eligible",
                    "criterion": "intraductal carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have evidence of germline or somatic BRCA1/2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 gene alteration via standard of care CLIA based assay detection. Testing will be confirmed centrally but results of central testing not required for enrollment.",
            "criterions": [
                {
                    "exact_snippets": "evidence of germline or somatic BRCA1/2, PALB2, RAD51B, RAD51C, RAD51D, RAD54L2, BARD1, FANCA, BRIP1, CHEK2, ATM, and CDK12 gene alteration",
                    "criterion": "gene alteration",
                    "requirements": [
                        {
                            "requirement_type": "genes",
                            "expected_value": [
                                "BRCA1/2",
                                "PALB2",
                                "RAD51B",
                                "RAD51C",
                                "RAD51D",
                                "RAD54L2",
                                "BARD1",
                                "FANCA",
                                "BRIP1",
                                "CHEK2",
                                "ATM",
                                "CDK12"
                            ]
                        },
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of metastatic disease as determined by radionuclide bone scan and CT/MRI. Lymph nodes must be less than 20 mm in the short (transverse) axis.",
            "criterions": [
                {
                    "exact_snippets": "No evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Lymph nodes must be less than 20 mm in the short (transverse) axis",
                    "criterion": "lymph node size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be candidates for RP and considered surgically resectable by urologic evaluation.",
            "criterions": [
                {
                    "exact_snippets": "candidates for RP",
                    "criterion": "candidacy for RP",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered surgically resectable by urologic evaluation",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": "urologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status of 0-1 within 28 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status of 0-1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 28 days prior to registration",
                    "criterion": "timeframe for ECOG Performance Status assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 28 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All screening labs to be obtained within 28 days prior to registration",
                    "criterion": "screening labs",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 28 days prior to registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count ≥ 3,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count ≥ 3,000/mcL",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count ≥ 1,500/mcL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count ≥ 1,500/mcL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 10 g/dL with no transfusion support in the past 28 days",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 10 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no transfusion support in the past 28 days",
                    "criterion": "transfusion support",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 28 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥ 100,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥ 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase, alanine aminotransferase ≤ 2.5×ULN, and total bilirubin ≤ 1.5 x Institutional upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase ... ≤ 2.5×ULN",
                    "criterion": "aspartate aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase ≤ 2.5×ULN",
                    "criterion": "alanine aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 1.5 x Institutional upper limit of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "Institutional upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Calculated creatinine clearance ≥ 51 mL/min based on Cockcroft-Gault formula or 24 hour urine. NOTE: See the protocol for Cockcroft-Gault formula or 24 hour urine.",
            "criterions": [
                {
                    "exact_snippets": "Calculated creatinine clearance ≥ 51 mL/min based on Cockcroft-Gault formula or 24 hour urine.",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation method",
                            "expected_value": [
                                "Cockcroft-Gault formula",
                                "24 hour urine"
                            ]
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 51,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy≥ 16 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy≥ 16 weeks.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 16,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must use a condom plus spermicide beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. See protocol for additional details.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must use a condom plus spermicide beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential.",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "condom",
                                "spermicide"
                            ]
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "beginning prior to treatment Cycle 1 Day 1, during treatment and for 3 months after the last dose of olaparib"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.",
                    "criterion": "contraceptive use by female partners",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "highly effective form of contraception"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "if they are of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.",
            "criterions": [
                {
                    "exact_snippets": "ability of the subject to understand and comply with study procedures",
                    "criterion": "ability to understand and comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "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": "* Active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "Active infection requiring systemic therapy.",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatments not allowed: hormone therapy for prostate cancer including orchiectomy, antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others), CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others), estrogens and radiation therapy. Prior bicalutamide is allowed if taken for < 4 weeks prior to registration and there is a washout period of 2 weeks prior to the initiation of study treatment. LHRH agonist/antagonist therapy is allowed if begun within 4 weeks of registration. Prior 5-alpha reductase inhibitors are allowed but require a washout period of 2 weeks to initiation of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatments not allowed: hormone therapy for prostate cancer including orchiectomy",
                    "criterion": "prior hormone therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatments not allowed: ... antiandrogens (including first-generation antiandrogens, enzalutamide, apalutamide and others)",
                    "criterion": "prior antiandrogens",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatments not allowed: ... CYP17 inhibitors (including abiraterone, TAK-700, galeterone, ketoconazole, and others)",
                    "criterion": "prior CYP17 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatments not allowed: ... estrogens",
                    "criterion": "prior estrogens",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatments not allowed: ... radiation therapy",
                    "criterion": "prior radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior bicalutamide is allowed if taken for < 4 weeks prior to registration and there is a washout period of 2 weeks prior to the initiation of study treatment",
                    "criterion": "prior bicalutamide",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "LHRH agonist/antagonist therapy is allowed if begun within 4 weeks of registration",
                    "criterion": "LHRH agonist/antagonist therapy",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "initiation period",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior 5-alpha reductase inhibitors are allowed but require a washout period of 2 weeks to initiation of study treatment",
                    "criterion": "prior 5-alpha reductase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with a PARP inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with a PARP inhibitor.",
                    "criterion": "PARP inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy",
                    "criterion": "acute infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "systemic antibacterial",
                                "antifungal",
                                "antiviral therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice).",
            "criterions": [
                {
                    "exact_snippets": "tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": [
                                "clinical history",
                                "physical examination",
                                "radiographic findings",
                                "TB testing"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known active hepatitis infection, positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody at screening. Testing is not required unless there was a prior known positive hepatitis B or C test or hepatitis is suspected at screening. Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.",
            "criterions": [
                {
                    "exact_snippets": "Known active hepatitis infection",
                    "criterion": "active hepatitis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "positive hepatitis C antibody",
                    "criterion": "hepatitis C antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus surface antigen",
                    "criterion": "hepatitis B virus surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatitis B virus core antibody",
                    "criterion": "hepatitis B virus core antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result",
                    "criterion": "active hepatitis B virus (HBV)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of chronic hepatitis B virus (HBV) infection ... HBV viral load must be undetectable on suppressive therapy",
                    "criterion": "chronic hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "viral load",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of hepatitis C virus (HCV) infection ... must have been treated and cured",
                    "criterion": "history of hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with HCV infection who are currently on treatment ... undetectable HCV viral load",
                    "criterion": "HCV infection on treatment",
                    "requirements": [
                        {
                            "requirement_type": "viral load",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known to have tested positive for human immunodeficiency virus (HIV) unless currently on effective anti-retroviral therapy with an undetectable viral load within 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Known to have tested positive for human immunodeficiency virus (HIV)",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unless currently on effective anti-retroviral therapy",
                    "criterion": "anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "effective"
                        }
                    ]
                },
                {
                    "exact_snippets": "with an undetectable viral load within 6 months",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe hepatic impairment (Child-Pugh Class C).",
            "criterions": [
                {
                    "exact_snippets": "Severe hepatic impairment (Child-Pugh Class C)",
                    "criterion": "hepatic impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "classification",
                            "expected_value": "Child-Pugh Class C"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.",
            "criterions": [
                {
                    "exact_snippets": "Patients unable to swallow orally administered medication",
                    "criterion": "ability to swallow medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with gastrointestinal disorders likely to interfere with absorption of the study medication",
                    "criterion": "gastrointestinal disorders",
                    "requirements": [
                        {
                            "requirement_type": "interference with absorption",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-existing condition that warrants long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily. Physiologic replacement is permitted. Topical, intra-articular steroids or inhaled corticosteroids are permitted.",
            "criterions": [
                {
                    "exact_snippets": "Pre-existing condition that warrants long-term corticosteroid use",
                    "criterion": "pre-existing condition",
                    "requirements": [
                        {
                            "requirement_type": "necessity for long-term corticosteroid use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "long-term corticosteroid use greater than the equivalent of 10 mg prednisone daily",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone daily"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Physiologic replacement is permitted",
                    "criterion": "physiologic replacement",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Topical, intra-articular steroids or inhaled corticosteroids are permitted",
                    "criterion": "topical, intra-articular, or inhaled corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "permitted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active cardiac disease, defined as:",
            "criterions": [
                {
                    "exact_snippets": "Active cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myocardial infarction within 6 months of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Myocardial infarction within 6 months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled angina within 3 months of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled angina within 3 months",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless an echocardiogram performed within 3 months of the screening visit results in a left ventricular ejection fraction that is ≥ 45%.",
            "criterions": [
                {
                    "exact_snippets": "Congestive heart failure New York Heart Association (NYHA) class 3 or 4",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of congestive heart failure NYHA class 3 or 4 in the past",
                    "criterion": "history of congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "NYHA class",
                            "expected_value": [
                                "3",
                                "4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of anthracycline or anthracenedione (mitoxantrone) treatment",
                    "criterion": "history of anthracycline or anthracenedione treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "echocardiogram performed within 3 months of the screening visit results in a left ventricular ejection fraction that is ≥ 45%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 3 months of the screening visit"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)",
            "criterions": [
                {
                    "exact_snippets": "History of clinically significant ventricular arrhythmias",
                    "criterion": "ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular fibrillation",
                    "criterion": "ventricular fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "torsade de pointes",
                    "criterion": "torsade de pointes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other clinically significant cardiovascular disease within 6 months of registration.",
            "criterions": [
                {
                    "exact_snippets": "Other clinically significant cardiovascular disease",
                    "criterion": "clinically significant cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months of registration",
                    "criterion": "time since cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled, potentially reversible cardiac conditions",
                    "criterion": "cardiac conditions",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "reversibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable ischemia",
                    "criterion": "ischemia",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled symptomatic arrhythmia",
                    "criterion": "symptomatic arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "QTcF prolongation >500 ms",
                    "criterion": "QTcF prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 500,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "electrolyte disturbances",
                    "criterion": "electrolyte disturbances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans.",
            "criterions": [
                {
                    "exact_snippets": "history of another malignancy",
                    "criterion": "history of another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer is under active treatment",
                    "criterion": "cancer under active treatment",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cancer can be seen on radiology scans",
                    "criterion": "cancer visible on radiology scans",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 4 weeks from start of treatment. Subjects must have recovered from any effects as the surgery as assessed by investigator discretion.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks from start of treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects must have recovered from any effects as the surgery",
                    "criterion": "recovery from surgery effects",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment with any investigational drug within 28 days prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with any investigational drug within 28 days prior to registration.",
                    "criterion": "treatment with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent toxicities Grade > 2 caused by previous cancer therapy (per Common Terminology Criteria for Adverse Event (CTCAE)).",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicities Grade > 2 caused by previous cancer therapy",
                    "criterion": "persistent toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.",
            "criterions": [
                {
                    "exact_snippets": "Patients with myelodysplastic syndrome",
                    "criterion": "myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myeloid leukemia",
                    "criterion": "acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of MDS/AML",
                    "criterion": "features suggestive of MDS/AML",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorders that prohibits obtaining informed consent.",
            "criterions": [
                {
                    "exact_snippets": "serious, uncontrolled medical disorder",
                    "criterion": "serious medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-malignant systemic disease",
                    "criterion": "non-malignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active, uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "recent (within 3 months) myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled major seizure disorder",
                    "criterion": "major seizure disorder",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "superior vena cava syndrome",
                    "criterion": "superior vena cava syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan",
                    "criterion": "interstitial bilateral lung disease",
                    "requirements": [
                        {
                            "requirement_type": "extent",
                            "expected_value": "extensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "any psychiatric disorders that prohibits obtaining informed consent",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "prohibits obtaining informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving any systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks prior to study treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving any ... radiotherapy (except for palliative reasons)",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks prior to study treatment"
                            }
                        },
                        {
                            "requirement_type": "purpose",
                            "expected_value": "palliative reasons"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of known strong CYP3A inhibitors. The required washout period prior to starting olaparib is 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong CYP3A inhibitors.",
                    "criterion": "concomitant use of strong CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is 2 weeks.",
                    "criterion": "washout period prior to starting olaparib",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong or moderate CYP3A inducers.",
                    "criterion": "concomitant use of CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital",
                    "criterion": "washout period for enzalutamide or phenobarbital",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting olaparib is ... 3 weeks for other agents.",
                    "criterion": "washout period for other agents",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).",
            "criterions": [
                {
                    "exact_snippets": "Previous allogenic bone marrow transplant",
                    "criterion": "allogenic bone marrow transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "double umbilical cord blood transplantation (dUCBT)",
                    "criterion": "double umbilical cord blood transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable, for timing refer to the protocol).",
            "criterions": [
                {
                    "exact_snippets": "Whole blood transfusions in the last 120 days prior to entry to the study",
                    "criterion": "whole blood transfusions",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "packed red blood cells and platelet transfusions are acceptable",
                    "criterion": "packed red blood cells and platelet transfusions",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to olaparib",
                    "criterion": "hypersensitivity to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of the product",
                    "criterion": "hypersensitivity to excipients of the product",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Subject must meet all of the following applicable inclusion criteria to participate in this study:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "Subjects meeting any of the criteria below may not participate in the study:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}