{
    "info": {
        "nct_id": "NCT03732820",
        "official_title": "A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study)",
        "inclusion_criteria": "1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.\n2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:\n\n   * Provision of informed consent for genetic research prior to collection of sample.\n   * Provision of informed consent for biomarker research prior to collection of sample.\n\n   If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.\n4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative.\n5. Histologically or cytologically confirmed prostate adenocarcinoma.\n6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan.\n7. First-line metastatic castration-resistant prostate cancer (mCRPC).\n8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study.\n9. Candidate for abiraterone therapy with documented evidence of progressive disease.\n10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.\n11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks.\n12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.\n13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study.\n14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone 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.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.\n2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).\n3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan.\n4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.\n5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).\n6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).\n7. History of uncontrolled pituitary or adrenal dysfunction.\n8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.\n9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.\n10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia.\n12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required.\n13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks.\n14. Patients who are unevaluable for both bone and soft tissue progression\n15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n16. Immunocompromised patients\n17. Patients with known active hepatitis infection (ie, hepatitis B or C).\n18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.\n19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.\n20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).\n21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.\n22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents.\n23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n24. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.\n26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone.\n27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).\n28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n29. Previous randomisation in the present study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Capable of giving signed informed consent",
                    "criterion": "informed consent capability",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "compliance with the requirements and restrictions listed in the informed consent form and in the study protocol",
                    "criterion": "compliance with informed consent and study protocol",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.",
            "criterions": [
                {
                    "exact_snippets": "Provision of signed and dated, written informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "dated",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. For inclusion in i) the optional exploratory genetic research and ii) the optional biomarker research, patients must fulfill the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "optional exploratory genetic research",
                    "criterion": "participation in optional exploratory genetic research",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "optional biomarker research",
                    "criterion": "participation in optional biomarker research",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provision of informed consent for genetic research prior to collection of sample.",
            "criterions": [
                {
                    "exact_snippets": "Provision of informed consent for genetic research",
                    "criterion": "informed consent for genetic research",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior to collection of sample",
                    "criterion": "collection of sample",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "after informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provision of informed consent for biomarker research prior to collection of sample.",
            "criterions": [
                {
                    "exact_snippets": "Provision of informed consent for biomarker research",
                    "criterion": "informed consent for biomarker research",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "collection of sample",
                    "criterion": "sample collection",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients must be ≥18 years of age (or ≥19 years of age in South Korea) at the time of signing the informed consent form. For patients enrolled in Japan who are <20 years of age, written informed consent should be obtained from the patient and from his legally acceptable representative.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be ≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "≥19 years of age in South Korea",
                    "criterion": "age in South Korea",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients enrolled in Japan who are <20 years of age",
                    "criterion": "age in Japan",
                    "requirements": [
                        {
                            "requirement_type": "maximum age",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Histologically or cytologically confirmed prostate adenocarcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Metastatic status defined as at least 1 documented metastatic lesion on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic status defined as at least 1 documented metastatic lesion",
                    "criterion": "metastatic status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on either a bone scan or a computed tomography(CT)/ magnetic resonance imaging (MRI) scan",
                    "criterion": "imaging method for metastatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "bone scan",
                                "computed tomography (CT)",
                                "magnetic resonance imaging (MRI)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. First-line metastatic castration-resistant prostate cancer (mCRPC).",
            "criterions": [
                {
                    "exact_snippets": "First-line metastatic castration-resistant prostate cancer (mCRPC)",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        },
                        {
                            "requirement_type": "resistance",
                            "expected_value": "castration-resistant"
                        },
                        {
                            "requirement_type": "treatment line",
                            "expected_value": "first-line"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy, with serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation. Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study.",
            "criterions": [
                {
                    "exact_snippets": "Ongoing androgen deprivation with gonadotropin-releasing hormone analogue or bilateral orchiectomy",
                    "criterion": "androgen deprivation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "serum testosterone <50 nanograms per decilitre (ng/dL) (<2.0 nanomoles per litre (nmol/L)) within 28 days before randomisation",
                    "criterion": "serum testosterone",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "nanograms per decilitre"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 2.0,
                                        "unit": "nanomoles per litre"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients receiving androgen deprivation therapy (ADT) at study entry should continue to do so throughout the study",
                    "criterion": "continuation of androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Candidate for abiraterone therapy with documented evidence of progressive disease.",
            "criterions": [
                {
                    "exact_snippets": "Candidate for abiraterone therapy",
                    "criterion": "abiraterone therapy candidacy",
                    "requirements": [
                        {
                            "requirement_type": "candidacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented evidence of progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "normal organ and bone marrow function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normal organ and bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "measured within 28 days prior to administration of study treatment",
                    "criterion": "measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days prior to administration of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Eastern Cooperative Oncology Group (ECOG) performance status 0-1, with no deterioration over the previous 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 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": "no deterioration over the previous 2 weeks",
                    "criterion": "performance status stability",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "no deterioration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Prior to randomisation, sites must confirm availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy taken during the screening window, which meets the minimum pathology and sample requirements in order to enable homologous recombination repair (HRR) status subgroup analysis of the primary endpoint radiographic progression-free survival (rPFS). If there is not written confirmation of the availability of tumour tissue prior to randomisation, the patient is not eligible for the study.",
            "criterions": [
                {
                    "exact_snippets": "availability of either an archival formalin fixed, paraffin embedded (FFPE) tumour tissue sample, or a new biopsy",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meets the minimum pathology and sample requirements",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "quality",
                            "expected_value": "meets minimum pathology and sample requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone 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.",
            "criterions": [
                {
                    "exact_snippets": "Male patients must use a condom during treatment and for 3 months after the last dose of olaparib+abiraterone when having sexual intercourse with a pregnant woman or with a woman of childbearing potential.",
                    "criterion": "male patients' condom use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during treatment and for 3 months after the last dose of olaparib+abiraterone"
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "when having sexual intercourse with a pregnant woman or with a woman of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.",
                    "criterion": "female partners' contraception use",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "if they are of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Has a known additional malignancy that has had progression or has required active treatment in the last 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has had progression",
                    "criterion": "malignancy progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "or has required active treatment",
                    "criterion": "active treatment for malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the last 5 years",
                    "criterion": "time since malignancy progression or treatment",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with myelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML) or with features suggestive of yelodysplastic syndrome (MDS)/ acute myeloid leukaemia (AML).",
            "criterions": [
                {
                    "exact_snippets": "Patients with myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "acute myeloid leukaemia (AML)",
                    "criterion": "acute myeloid leukaemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of yelodysplastic syndrome (MDS)",
                    "criterion": "features suggestive of myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of ... acute myeloid leukaemia (AML)",
                    "criterion": "features suggestive of acute myeloid leukaemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Clinically significant cardiovascular disease Association Class II-IV heart failure or cardiac ejection fraction measurement of <50% during screening as assessed by echocardiography or multigated acquisition scan.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Class II-IV heart failure",
                    "criterion": "heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Class II",
                                "Class III",
                                "Class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac ejection fraction measurement of <50%",
                    "criterion": "cardiac ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as assessed by echocardiography or multigated acquisition scan",
                    "criterion": "assessment method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "echocardiography",
                                "multigated acquisition scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Planned or scheduled cardiac surgery or percutaneous coronary intervention procedure.",
            "criterions": [
                {
                    "exact_snippets": "Planned or scheduled cardiac surgery",
                    "criterion": "cardiac surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned or scheduled",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Planned or scheduled ... percutaneous coronary intervention procedure",
                    "criterion": "percutaneous coronary intervention procedure",
                    "requirements": [
                        {
                            "requirement_type": "planned or scheduled",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Prior revascularisation procedure (significant coronary, carotid, or peripheral artery stenosis).",
            "criterions": [
                {
                    "exact_snippets": "Prior revascularisation procedure",
                    "criterion": "prior revascularisation procedure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "significant coronary ... stenosis",
                    "criterion": "coronary artery stenosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... carotid ... stenosis",
                    "criterion": "carotid artery stenosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "significant ... peripheral artery stenosis",
                    "criterion": "peripheral artery stenosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Uncontrolled hypertension (systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)).",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg)",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 160,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diastolic blood pressure (BP) ≥95 millimeters of mercury (mmHg)",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 95,
                                "unit": "mmHg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. History of uncontrolled pituitary or adrenal dysfunction.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled pituitary ... dysfunction",
                    "criterion": "pituitary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled ... adrenal dysfunction",
                    "criterion": "adrenal dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Active infection or other medical condition that would make prednisone/prednisolone use contraindicated.",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other medical condition that would make prednisone/prednisolone use contraindicated",
                    "criterion": "medical condition contraindicating prednisone/prednisolone use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Any chronic medical condition requiring a systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day.",
            "criterions": [
                {
                    "exact_snippets": "chronic medical condition requiring a systemic dose of corticosteroid",
                    "criterion": "chronic medical condition requiring corticosteroid",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "systemic dose of corticosteroid >10 milligrams (mg) prednisone/prednisolone per day",
                    "criterion": "systemic dose of corticosteroid",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg prednisone/prednisolone per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients who are considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.",
            "criterions": [
                {
                    "exact_snippets": "poor medical risk due to a serious, uncontrolled medical disorder",
                    "criterion": "medical disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "poor medical risk due to a ... non-malignant systemic disease",
                    "criterion": "non-malignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "poor medical risk due to a ... active, uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patients with brain metastases. A scan to confirm the absence of brain metastases is not required.",
            "criterions": [
                {
                    "exact_snippets": "Patients with brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Patients with spinal cord compression are excluded unless they are considered to have received definitive treatment for this and have evidence of clinically stable disease for 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patients with spinal cord compression are excluded",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless they are considered to have received definitive treatment",
                    "criterion": "definitive treatment for spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "have evidence of clinically stable disease for 4 weeks",
                    "criterion": "clinically stable disease",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Patients who are unevaluable for both bone and soft tissue progression",
            "criterions": [
                {
                    "exact_snippets": "unevaluable for both bone and soft tissue progression",
                    "criterion": "bone progression",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unevaluable for both bone and soft tissue progression",
                    "criterion": "soft tissue progression",
                    "requirements": [
                        {
                            "requirement_type": "evaluability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Patients who are unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.",
            "criterions": [
                {
                    "exact_snippets": "Patients who are unable to swallow orally administered medication",
                    "criterion": "ability to swallow orally administered 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 of the study medication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Immunocompromised patients",
            "criterions": [
                {
                    "exact_snippets": "Immunocompromised patients",
                    "criterion": "immunocompromised status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Patients with known active hepatitis infection (ie, hepatitis B or C).",
            "criterions": [
                {
                    "exact_snippets": "known active hepatitis infection (ie, hepatitis B or C)",
                    "criterion": "hepatitis infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.",
            "criterions": [
                {
                    "exact_snippets": "Any previous treatment with Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) inhibitor, including olaparib.",
                    "criterion": "previous treatment with PARP inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment. Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment.",
                    "criterion": "systemic chemotherapy or radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who receive palliative radiotherapy need to stop radiotherapy 1 week before randomisation.",
                    "criterion": "palliative radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor (eg, abiraterone, orteronel).",
            "criterions": [
                {
                    "exact_snippets": "Any previous exposure to a Cytochrome P450 (CYP) 17 (17α-hydroxylase/C17,20-lyase) inhibitor",
                    "criterion": "previous exposure to CYP17 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "(eg, abiraterone, orteronel)",
                    "criterion": "specific CYP17 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "abiraterone",
                                "orteronel"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors (eg, itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg, ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong Cytochrome P450 (CYP) 3A inhibitors",
                    "criterion": "concomitant use of strong CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... moderate CYP3A inhibitors",
                    "criterion": "concomitant use of moderate CYP3A inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The required washout period prior to starting study treatment is 2 weeks",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers (eg, phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine or St John's wort) or moderate Cytochrome P450 (CYP) 3A inducers (eg, bosentan, efavirenz or modafinil). The required period prior to starting study treatment is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents.",
            "criterions": [
                {
                    "exact_snippets": "Concomitant use of known strong Cytochrome P450 (CYP) 3A inducers",
                    "criterion": "concomitant use of strong CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Concomitant use of ... moderate Cytochrome P450 (CYP) 3A inducers",
                    "criterion": "concomitant use of moderate CYP3A inducers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 2 weeks of starting study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients must have recovered from any effects of any major surgery",
                    "criterion": "recovery from major surgery",
                    "requirements": [
                        {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. 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": "25. Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.",
            "criterions": [
                {
                    "exact_snippets": "Participation in another clinical study with an investigational product or investigational medical devices within 1 month of randomisation.",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "26. History of hypersensitivity to olaparib or abiraterone, any of the excipients of olaparib or abiraterone, or drugs with a similar chemical structure or class to olaparib or abiraterone.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to olaparib",
                    "criterion": "hypersensitivity to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... abiraterone",
                    "criterion": "hypersensitivity to abiraterone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of olaparib",
                    "criterion": "hypersensitivity to excipients of olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any of the excipients of ... abiraterone",
                    "criterion": "hypersensitivity to excipients of abiraterone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... drugs with a similar chemical structure or class to olaparib",
                    "criterion": "hypersensitivity to drugs with similar chemical structure or class to olaparib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... drugs with a similar chemical structure or class to ... abiraterone",
                    "criterion": "hypersensitivity to drugs with similar chemical structure or class to abiraterone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "27. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and Merck staff and/or staff at the study site).",
            "criterions": [
                {
                    "exact_snippets": "Involvement in the planning and/or conduct of the study",
                    "criterion": "involvement in study planning/conduct",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "28. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.",
            "criterions": [
                {
                    "exact_snippets": "patient is unlikely to comply with study procedures, restrictions and requirements",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "likely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "29. Previous randomisation in the present study.",
            "criterions": [
                {
                    "exact_snippets": "Previous randomisation in the present study.",
                    "criterion": "randomisation in the present study",
                    "requirements": [
                        {
                            "requirement_type": "previous occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "If a patient declines to participate in the optional exploratory genetic research or the optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.",
            "criterions": [
                {
                    "exact_snippets": "declines to participate in the optional exploratory genetic research",
                    "criterion": "participation in optional exploratory genetic research",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "declines to participate in the optional biomarker research",
                    "criterion": "participation in optional biomarker research",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "11. Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAEs] grade >2) caused by previous cancer therapy, excluding alopecia.",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicities ... CTCAEs grade >2",
                    "criterion": "persistent toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "CTCAEs grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "caused by previous cancer therapy",
                    "criterion": "cause of toxicities",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "previous cancer therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}