{
    "info": {
        "nct_id": "NCT06120491",
        "official_title": "A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)",
        "inclusion_criteria": "* Male ≥ 18 years of age.\n* Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.\n* Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.\n* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation.\n* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.\n* Provision of FFPE tumour tissue sample and blood sample (for ctDNA).\n* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 130 Years",
        "exclusion_criteria": "* Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.\n* Participants with any known predisposition to bleeding.\n* Any history of persisting (> 2 weeks) severe cytopenia.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Cardiac criteria, including history of arrhythmia and cardiovascular disease.\n* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.\n* Prior treatment within 14 days with blood product support or growth factor support.\n* Participants who are unevaluable for both bone and soft tissue progression.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Histologically documented prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "histologically"
                        }
                    ]
                },
                {
                    "exact_snippets": "de novo or recurrent",
                    "criterion": "prostate adenocarcinoma status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "de novo",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "castration-sensitive",
                    "criterion": "prostate adenocarcinoma sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": "castration-sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible",
                    "criterion": "pathologic features",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "small cell",
                                "neuroendocrine",
                                "sarcomatoid",
                                "spindle cell",
                                "signet cell"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease as documented by the investigator prior to randomisation",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clear evidence of ≥ 1 bone lesion",
                    "criterion": "bone lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clear evidence of ... ≥ 1 soft tissue lesion",
                    "criterion": "soft tissue lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "suitable for repeated assessment with CT and/or MRI",
                    "criterion": "lesion suitability for imaging",
                    "requirements": [
                        {
                            "requirement_type": "suitability for repeated assessment",
                            "expected_value": [
                                "CT",
                                "MRI"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and < 4 months prior to randomisation.",
            "criterions": [
                {
                    "exact_snippets": "Participant is receiving ADT with a GnRH analogue",
                    "criterion": "ADT with a GnRH analogue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has undergone bilateral orchiectomy",
                    "criterion": "bilateral orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting ≥ 14 days and < 4 months prior to randomisation",
                    "criterion": "time since start of treatment",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 14,
                                        "unit": "days"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 4,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "no deterioration over the 2 weeks prior to randomisation",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "no deterioration over the 2 weeks prior to randomisation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Provision of FFPE tumour tissue sample and blood sample (for ctDNA).",
            "criterions": [
                {
                    "exact_snippets": "Provision of FFPE tumour tissue sample",
                    "criterion": "FFPE tumour tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blood sample (for ctDNA)",
                    "criterion": "blood sample for ctDNA",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed HRRm status by central tumour tissue and/or ctDNA test is required",
                    "criterion": "HRRm status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ and bone marrow function as described in study protocol.",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ ... function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as described in study protocol"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as described in study protocol"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "Participants must not father children",
                    "criterion": "father children",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "donate sperm",
                    "criterion": "donate sperm",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "from signing ICF, during the study intervention and for 6 months after the last dose of study intervention",
                    "criterion": "time period for restrictions",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from signing ICF, during the study intervention and for 6 months after the last dose of study intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.",
            "criterions": [
                {
                    "exact_snippets": "Participants must use a condom ... with all sexual partners.",
                    "criterion": "condom use",
                    "requirements": [
                        {
                            "requirement_type": "time period",
                            "expected_value": "from signing ICF, during study intervention, and for 6 months after the last dose of study drug"
                        },
                        {
                            "requirement_type": "applicability",
                            "expected_value": "with all sexual partners"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 130 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 130 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 130,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participants with a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.",
            "criterions": [
                {
                    "exact_snippets": "history of MDS/AML",
                    "criterion": "history of MDS/AML",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "features suggestive of MDS/AML",
                    "criterion": "features suggestive of MDS/AML",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with any known predisposition to bleeding.",
            "criterions": [
                {
                    "exact_snippets": "any known predisposition to bleeding",
                    "criterion": "predisposition to bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any history of persisting (> 2 weeks) severe cytopenia.",
            "criterions": [
                {
                    "exact_snippets": "Any history of persisting (> 2 weeks) severe cytopenia.",
                    "criterion": "severe cytopenia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.",
            "criterions": [
                {
                    "exact_snippets": "Refractory nausea and vomiting",
                    "criterion": "refractory nausea and vomiting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic gastrointestinal diseases",
                    "criterion": "chronic gastrointestinal diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to swallow the formulated product",
                    "criterion": "ability to swallow the formulated product",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA",
                    "criterion": "previous significant bowel resection",
                    "requirements": [
                        {
                            "requirement_type": "impact on absorption",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of another primary malignancy, with exceptions.",
            "criterions": [
                {
                    "exact_snippets": "History of another primary malignancy",
                    "criterion": "history of another primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.",
                    "criterion": "persistent toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "CTCAE Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.",
            "criterions": [
                {
                    "exact_snippets": "Spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable"
                        },
                        {
                            "requirement_type": "steroid requirement",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since steroid use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac criteria, including history of arrhythmia and cardiovascular disease.",
            "criterions": [
                {
                    "exact_snippets": "history of arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.",
            "criterions": [
                {
                    "exact_snippets": "Any prior anticancer pharmacotherapy",
                    "criterion": "prior anticancer pharmacotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgery for metastatic prostate cancer",
                    "criterion": "surgery for metastatic prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment within 14 days with blood product support or growth factor support.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment within 14 days with blood product support",
                    "criterion": "prior treatment with blood product support",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment within 14 days with ... growth factor support",
                    "criterion": "prior treatment with growth factor support",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants 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
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}