{
    "info": {
        "nct_id": "NCT03551782",
        "official_title": "An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination With Apalutamide in Subjects With Metastatic Castration-Resistant Prostate Cancer",
        "inclusion_criteria": "* Pathologically confirmed adenocarcinoma of the prostate. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) on screening biopsy may be eligible for cohort 5\n* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility. If lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis and above the level of the iliac bifurcation\n* Progressed while on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), enzalutamide, darolutamide, or apalutamide for mCRPC. No washout is required and no additional therapy may have been administered between discontinuation of AR-targeted the agent and study treatment. Participants will be assigned to cohorts based on the results of the biomarker panel. Cohort 1: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P); Cohort 2: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 3: Biomarker-positive participants who progressed on AA-P; Cohort 4: Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 5: Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide\n* Surgical or medical castration, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL). If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs (participant who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of study drug and must be continued throughout the study\n* Eastern Cooperative Oncology Group Performance Status (ECOG) prostate-specific (PS) grade of 0 or 1\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Initial diagnosis of primary prostatic neuroendocrine or small cell carcinoma\n* Brain metastases\n* Prior treatment with an anti-programmed cell death receptor-1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody\n* Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC)\n* Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Pathologically confirmed adenocarcinoma of the prostate. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) on screening biopsy may be eligible for cohort 5",
            "criterions": [
                {
                    "exact_snippets": "Pathologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) on screening biopsy",
                    "criterion": "treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "method of detection",
                            "expected_value": "screening biopsy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility. If lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis and above the level of the iliac bifurcation",
            "criterions": [
                {
                    "exact_snippets": "Metastatic disease as documented by technetium-99m (99mTc) bone scan",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "technetium-99m (99mTc) bone scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans",
                    "criterion": "metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "computed tomography (CT)",
                                "magnetic resonance imaging (MRI) scans"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility",
                    "criterion": "CT-portion of PET/CT scan",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph node metastasis ... above the level of the iliac bifurcation",
                    "criterion": "lymph node metastasis",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "above the level of the iliac bifurcation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressed while on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), enzalutamide, darolutamide, or apalutamide for mCRPC. No washout is required and no additional therapy may have been administered between discontinuation of AR-targeted the agent and study treatment. Participants will be assigned to cohorts based on the results of the biomarker panel. Cohort 1: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on abiraterone acetate plus prednisone/prednisolone (AA-P); Cohort 2: Biomarker-negative or biomarker-unknown participants with adenocarcinoma (and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 3: Biomarker-positive participants who progressed on AA-P; Cohort 4: Biomarker-positive participants who progressed on apalutamide, darolutamide, or enzalutamide; Cohort 5: Biomarker-negative participants with t-SCNC who progressed on treatment with AA-P, apalutamide, darolutamide, or enzalutamide",
            "criterions": [
                {
                    "exact_snippets": "Progressed while on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), enzalutamide, darolutamide, or apalutamide",
                    "criterion": "progression on therapy",
                    "requirements": [
                        {
                            "requirement_type": "therapy",
                            "expected_value": [
                                "abiraterone acetate plus prednisone/prednisolone (AA-P)",
                                "enzalutamide",
                                "darolutamide",
                                "apalutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No washout is required",
                    "criterion": "washout period",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "no additional therapy may have been administered between discontinuation of AR-targeted the agent and study treatment",
                    "criterion": "additional therapy between AR-targeted agent and study treatment",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Biomarker-negative or biomarker-unknown",
                    "criterion": "biomarker status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "negative",
                                "unknown"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "adenocarcinoma (and not t-SCNC)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "adenocarcinoma"
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "t-SCNC"
                        }
                    ]
                },
                {
                    "exact_snippets": "Biomarker-positive",
                    "criterion": "biomarker status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "t-SCNC",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "t-SCNC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgical or medical castration, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL). If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs (participant who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of study drug and must be continued throughout the study",
            "criterions": [
                {
                    "exact_snippets": "Surgical or medical castration",
                    "criterion": "castration",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "surgical",
                                "medical"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "testosterone levels of less than (<)50 nanogram per deciliter (ng/dL)",
                    "criterion": "testosterone levels",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs",
                    "criterion": "GnRH analog treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "this therapy must have been initiated at least 4 weeks prior to first dose of study drug",
                    "criterion": "GnRH analog treatment initiation",
                    "requirements": [
                        {
                            "requirement_type": "time since initiation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be continued throughout the study",
                    "criterion": "GnRH analog treatment continuation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group Performance Status (ECOG) prostate-specific (PS) grade of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG) ... grade of 0 or 1",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Initial diagnosis of primary prostatic neuroendocrine or small cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "Initial diagnosis of primary prostatic neuroendocrine",
                    "criterion": "primary prostatic neuroendocrine carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "initial"
                        }
                    ]
                },
                {
                    "exact_snippets": "Initial diagnosis of ... small cell carcinoma",
                    "criterion": "small cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "initial"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with an anti-programmed cell death receptor-1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with an anti-programmed cell death receptor-1 (PD-1)",
                    "criterion": "prior treatment with anti-PD-1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with an ... anti-programmed cell death ligand 1 (PD-L1)",
                    "criterion": "prior treatment with anti-PD-L1 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior treatment with an ... anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody",
                    "criterion": "prior treatment with anti-CTLA-4 antibody",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC)",
            "criterions": [
                {
                    "exact_snippets": "Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC)",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "docetaxel for hormone-sensitive prostate cancer (HSPC)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors",
                    "criterion": "prior therapy with PARP inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}