{
    "info": {
        "nct_id": "NCT03805594",
        "official_title": "Immunogenic Priming With PSMA-Targeted Radioligand Therapy in Advanced Prostate Cancer: A Phase 1b Study of 177Lu-PSMA-617 in Combination With Pembrolizumab",
        "inclusion_criteria": "* The subject is able and willing to comply with study procedures and provide signed and dated informed consent\n* Histologically confirmed prostate adenocarcinoma. De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype. Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not an exclusion\n* A minimum of three PSMA-avid lesions on baseline 68Ga-PSMA-11 PET, with positive lesions defined as those with maximum standardized uptake value (SUVmax) values greater than liver.\n* Progressive metastatic castration-resistant prostate cancer by Prostate Cancer Working Group (PCWG)3 criteria at the time of study entry\n* Castrate level of serum testosterone at study entry (< 50 ng/dL). Participants without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study\n* Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide\n* Absolute neutrophil count > 1.5 x 10^9/L\n* Hemoglobin > 9.0 g/dL\n* Platelet count > 100,000/microliter\n* Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) > 50 ml/min by Cockcroft-Gault or 24 hour urine collection\n* Total bilirubin =< 1.5 x ULN. In participants with known or suspected Gilbert's disease, direct bilirubin =< ULN\n* Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN (<= 5 x ULN in participants with liver metastases)\n* No other systemic anti-cancer therapies administered other than LHRH analogue within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Adverse events related to prior anti-cancer treatment other than LHRH analog treatment must have recovered to Grade <= 1 with the exception of any grade alopecia and grade <= 2 neuropathy.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must use appropriate methods of contraception during study treatment and for at least 60 days after last study treatment\n\n  * Participants who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential\n  * Participants who have undergone vasectomy themselves should also be considered to be of childbearing potential\n  * Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g. condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception\n* Participants must provide consent to comply to recommended radioprotection precautions during study\n* Participants willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. Bone or soft tissue lesion is allowed\n* Measurable disease by RECIST 1.1 criteria\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Untreated brain metastases at study entry. Participants with previously treated brain metastases are eligible provided the following criteria are all met:\n\n  * Last treatment was > 28 days prior to cycle 1 day 1 (C1D1)\n  * No evidence of new/progressive brain metastases is observed on magnetic resonance imaging (MRI) obtained during screening window\n  * Patient is clinically stable without requirement of steroid treatment for at least 14 days prior to first dose of study treatment\n* Receipt of prior PSMA-directed treatment (e.g. radiotherapy, immunotherapy, or antibody-drug conjugate)\n* Prior enrollment on clinical study investigating Lu-PSMA-based radioligand therapy\n* Prior treatment with radium-223 or other radioisotope for the treatment of prostate cancer\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease\n* Receipt of prior pembrolizumab or another immune checkpoint inhibitor (e.g. nivolumab, ipilimumab)\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment\n\n  * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent\n* Receipt of taxane chemotherapy applied in the castration-resistant setting. Prior receipt of taxane chemotherapy in the hormone-sensitive setting is allowed\n* Grade > 2 peripheral neuropathy at the time of study entry\n* Has severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g. neomercazole, carbimazole, etc.) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g. in Graves? disease) is not considered a form of systemic treatment of an autoimmune disease\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 mg daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug\n* Has a history of (non-infectious) ≥ grade 2 pneumonitis/interstitial lung disease that required steroids within past 2 years or has current ≥ grade 1 pneumonitis/interstitial lung disease at the time of study enrollment..\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n* Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent\n* Has clinically significant cardiovascular disease including, but not limited to:\n\n  * Uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure\n  * Uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months before study entry\n  * Clinically significant arrhythmias not controlled by medication. Chronic rate controlled or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation\n* Prior external beam radiation involving >= 25% of bone marrow or within 14 days of start of protocol therapy\n* Major surgery within 28 days of study treatment\n\n  *Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) (screening not required)\n* Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection (screening not required)\n* Has a known history of active Bacillus tuberculosis (TB)\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures\n* History of bleeding diathesis and not currently on anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* The subject is able and willing to comply with study procedures and provide signed and dated informed consent",
            "criterions": [
                {
                    "exact_snippets": "The subject is able and willing to comply with study procedures",
                    "criterion": "compliance with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability and willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provide signed and dated informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed and dated",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed prostate adenocarcinoma. De novo small cell neuroendocrine prostate cancer will not be allowed due to putative lower PSMA expression in this tumor subtype. Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not an exclusion",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "De novo small cell neuroendocrine prostate cancer will not be allowed",
                    "criterion": "de novo small cell neuroendocrine prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Treatment-emergent small cell neuroendocrine prostate cancer detected in metastatic tumor biopsy is not an exclusion",
                    "criterion": "treatment-emergent small cell neuroendocrine prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A minimum of three PSMA-avid lesions on baseline 68Ga-PSMA-11 PET, with positive lesions defined as those with maximum standardized uptake value (SUVmax) values greater than liver.",
            "criterions": [
                {
                    "exact_snippets": "A minimum of three PSMA-avid lesions on baseline 68Ga-PSMA-11 PET",
                    "criterion": "PSMA-avid lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lesions"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "positive lesions defined as those with maximum standardized uptake value (SUVmax) values greater than liver",
                    "criterion": "SUVmax of lesions",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "liver SUVmax"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressive metastatic castration-resistant prostate cancer by Prostate Cancer Working Group (PCWG)3 criteria at the time of study entry",
            "criterions": [
                {
                    "exact_snippets": "Progressive metastatic castration-resistant prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "metastatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "castration-resistant",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Castrate level of serum testosterone at study entry (< 50 ng/dL). Participants without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study",
            "criterions": [
                {
                    "exact_snippets": "Castrate level of serum testosterone at study entry (< 50 ng/dL)",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment",
                    "criterion": "LHRH analogue treatment",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "required for participants without prior bilateral orchiectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide",
            "criterions": [
                {
                    "exact_snippets": "Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide",
                    "criterion": "progression on second generation androgen signaling inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "specific inhibitors",
                            "expected_value": [
                                "abiraterone",
                                "apalutamide",
                                "darolutamide",
                                "enzalutamide"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count > 1.5 x 10^9/L",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count > 1.5 x 10^9/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin > 9.0 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin > 9.0 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count > 100,000/microliter",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 100,000/microliter",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "microliter"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =< 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (GFR) > 50 ml/min by Cockcroft-Gault or 24 hour urine collection",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =< 1.5 x upper limit of normal (ULN)",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "estimated glomerular filtration rate (GFR) > 50 ml/min by Cockcroft-Gault or 24 hour urine collection",
                    "criterion": "estimated glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin =< 1.5 x ULN. In participants with known or suspected Gilbert's disease, direct bilirubin =< ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin =< 1.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "In participants with known or suspected Gilbert's disease, direct bilirubin =< ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other systemic anti-cancer therapies administered other than LHRH analogue within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment. Adverse events related to prior anti-cancer treatment other than LHRH analog treatment must have recovered to Grade <= 1 with the exception of any grade alopecia and grade <= 2 neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "No other systemic anti-cancer therapies administered other than LHRH analogue within 14 days, or 5 half-lives, whichever is shorter, prior to initiation of study treatment.",
                    "criterion": "systemic anti-cancer therapies",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Adverse events related to prior anti-cancer treatment other than LHRH analog treatment must have recovered to Grade <= 1",
                    "criterion": "adverse events related to prior anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of any grade alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "grade <= 2 neuropathy",
                    "criterion": "neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must use appropriate methods of contraception during study treatment and for at least 60 days after last study treatment",
            "criterions": [
                {
                    "exact_snippets": "Participants must use appropriate methods of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 60 days after last study treatment",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are sexually active should consider their female partner to be of childbearing potential if she has experienced menarche and is not postmenopausal (defined as amenorrhea > 24 consecutive months) or has not undergone successful surgical sterilization. Even women who use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide) should be considered to be of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "sexually active",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "female partner ... of childbearing potential",
                    "criterion": "female partner's childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced menarche",
                    "criterion": "menarche",
                    "requirements": [
                        {
                            "requirement_type": "experience",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not postmenopausal (defined as amenorrhea > 24 consecutive months)",
                    "criterion": "postmenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "amenorrhea > 24 consecutive months",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not undergone successful surgical sterilization",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "use contraceptive hormones (oral, implanted, or injected), an intrauterine device, or barrier methods (diaphragms, condoms, spermicide)",
                    "criterion": "contraceptive use",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "contraceptive hormones",
                                "intrauterine device",
                                "barrier methods"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have undergone vasectomy themselves should also be considered to be of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "Participants who have undergone vasectomy themselves",
                    "criterion": "vasectomy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "considered to be of childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "considered to be of childbearing potential"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acceptable methods of contraception include continuous total abstinence, or double-barrier method of birth control (e.g. condoms used with spermicide, or condoms used with oral contraceptives). Periodic abstinence and withdrawal are not acceptable methods of contraception",
            "criterions": [
                {
                    "exact_snippets": "Acceptable methods of contraception include continuous total abstinence",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": [
                                "continuous total abstinence"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "double-barrier method of birth control (e.g. condoms used with spermicide, or condoms used with oral contraceptives)",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": [
                                "double-barrier method of birth control"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Periodic abstinence and withdrawal are not acceptable methods of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": [
                                "not periodic abstinence",
                                "not withdrawal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must provide consent to comply to recommended radioprotection precautions during study",
            "criterions": [
                {
                    "exact_snippets": "Participants must provide consent",
                    "criterion": "consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "comply to recommended radioprotection precautions",
                    "criterion": "compliance with radioprotection precautions",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. Bone or soft tissue lesion is allowed",
            "criterions": [
                {
                    "exact_snippets": "Participants willing to undergo tumor biopsy",
                    "criterion": "willingness to undergo tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion safely accessible to tumor biopsy",
                    "criterion": "lesion accessibility",
                    "requirements": [
                        {
                            "requirement_type": "accessibility",
                            "expected_value": "safely accessible"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone or soft tissue lesion is allowed",
                    "criterion": "lesion type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "bone",
                                "soft tissue"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease by RECIST 1.1 criteria",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease by RECIST 1.1 criteria",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": "RECIST 1.1 criteria"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Untreated brain metastases at study entry. Participants with previously treated brain metastases are eligible provided the following criteria are all met:",
            "criterions": [
                {
                    "exact_snippets": "Untreated brain metastases at study entry.",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with previously treated brain metastases are eligible provided the following criteria are all met:",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "previously treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Last treatment was > 28 days prior to cycle 1 day 1 (C1D1)",
            "criterions": [
                {
                    "exact_snippets": "Last treatment was > 28 days prior to cycle 1 day 1 (C1D1)",
                    "criterion": "time since last treatment",
                    "requirements": [
                        {
                            "requirement_type": "time interval",
                            "expected_value": {
                                "operator": ">",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of new/progressive brain metastases is observed on magnetic resonance imaging (MRI) obtained during screening window",
            "criterions": [
                {
                    "exact_snippets": "No evidence of new/progressive brain metastases is observed on magnetic resonance imaging (MRI)",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is clinically stable without requirement of steroid treatment for at least 14 days prior to first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "clinically stable",
                    "criterion": "clinical stability",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "stable"
                        }
                    ]
                },
                {
                    "exact_snippets": "without requirement of steroid treatment",
                    "criterion": "steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 14 days prior to first dose of study treatment",
                    "criterion": "time since last steroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of prior PSMA-directed treatment (e.g. radiotherapy, immunotherapy, or antibody-drug conjugate)",
            "criterions": [
                {
                    "exact_snippets": "Receipt of prior PSMA-directed treatment",
                    "criterion": "prior PSMA-directed treatment",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior enrollment on clinical study investigating Lu-PSMA-based radioligand therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior enrollment on clinical study investigating Lu-PSMA-based radioligand therapy",
                    "criterion": "enrollment on clinical study",
                    "requirements": [
                        {
                            "requirement_type": "specific study",
                            "expected_value": "Lu-PSMA-based radioligand therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with radium-223 or other radioisotope for the treatment of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with radium-223 or other radioisotope",
                    "criterion": "prior treatment with radium-223 or other radioisotope",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease",
            "criterions": [
                {
                    "exact_snippets": "Has received prior radiotherapy within 2 weeks of start of study treatment",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants must have recovered from all radiation-related toxicities",
                    "criterion": "radiation-related toxicities",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not require corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not have had radiation pneumonitis",
                    "criterion": "radiation pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A 1-week washout is permitted for palliative radiation (=< 2 weeks of radiotherapy) to non-central nervous system (CNS) disease",
                    "criterion": "palliative radiation to non-CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "washout period",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "week"
                            }
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of prior pembrolizumab or another immune checkpoint inhibitor (e.g. nivolumab, ipilimumab)",
            "criterions": [
                {
                    "exact_snippets": "Receipt of prior pembrolizumab",
                    "criterion": "prior pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Receipt of prior ... another immune checkpoint inhibitor (e.g. nivolumab, ipilimumab)",
                    "criterion": "prior immune checkpoint inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "currently participating in ... a study of an investigational agent",
                    "criterion": "participation in a study of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study of an investigational agent",
                    "criterion": "past participation in a study of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has used an investigational device within 4 weeks prior to the first dose of study treatment",
                    "criterion": "use of an investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent",
            "criterions": [
                {
                    "exact_snippets": "Participants who have entered the follow-up phase of an investigational study",
                    "criterion": "participation in investigational study follow-up phase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "4 weeks after the last dose of the previous investigational agent",
                    "criterion": "time since last dose of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receipt of taxane chemotherapy applied in the castration-resistant setting. Prior receipt of taxane chemotherapy in the hormone-sensitive setting is allowed",
            "criterions": [
                {
                    "exact_snippets": "Receipt of taxane chemotherapy applied in the castration-resistant setting.",
                    "criterion": "taxane chemotherapy in castration-resistant setting",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior receipt of taxane chemotherapy in the hormone-sensitive setting is allowed",
                    "criterion": "taxane chemotherapy in hormone-sensitive setting",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Grade > 2 peripheral neuropathy at the time of study entry",
            "criterions": [
                {
                    "exact_snippets": "Grade > 2 peripheral neuropathy",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has severe hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients",
            "criterions": [
                {
                    "exact_snippets": "severe hypersensitivity (>= grade 3) to pembrolizumab",
                    "criterion": "hypersensitivity to pembrolizumab",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "severe hypersensitivity (>= grade 3) to ... any of its excipients",
                    "criterion": "hypersensitivity to pembrolizumab excipients",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) or treatment with drugs (e.g. neomercazole, carbimazole, etc.) that function to decrease the generation of thyroid hormone by a hyperfunctioning thyroid gland (e.g. in Graves? disease) is not considered a form of systemic treatment of an autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Has an active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that has required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 mg daily or other form of immunosuppressive therapy within 7 days prior to first dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving systemic steroid therapy at a prednisone equivalent dose of > 10 mg daily",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other form of immunosuppressive therapy within 7 days prior to first dose of study drug",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days prior to first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of (non-infectious) ≥ grade 2 pneumonitis/interstitial lung disease that required steroids within past 2 years or has current ≥ grade 1 pneumonitis/interstitial lung disease at the time of study enrollment..",
            "criterions": [
                {
                    "exact_snippets": "history of (non-infectious) ≥ grade 2 pneumonitis/interstitial lung disease that required steroids within past 2 years",
                    "criterion": "history of pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within past 2 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "current ≥ grade 1 pneumonitis/interstitial lung disease at the time of study enrollment",
                    "criterion": "current pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "at the time of study enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug.",
                    "criterion": "live or live-attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Administration of killed vaccines is allowed.",
                    "criterion": "killed vaccine",
                    "requirements": [
                        {
                            "requirement_type": "administration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent",
            "criterions": [
                {
                    "exact_snippets": "age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "ability to give informed consent",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "general medical ... condition",
                    "criterion": "general medical condition",
                    "requirements": [
                        {
                            "requirement_type": "ability to give informed consent",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric condition",
                    "criterion": "psychiatric condition",
                    "requirements": [
                        {
                            "requirement_type": "ability to give informed consent",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physiologic status",
                    "criterion": "physiologic status",
                    "requirements": [
                        {
                            "requirement_type": "ability to give informed consent",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has clinically significant cardiovascular disease including, but not limited to:",
            "criterions": [
                {
                    "exact_snippets": "clinically significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association class 3",
                                "New York Heart Association class 4"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled angina, history of myocardial infarction, unstable angina or stroke within 6 months before study entry",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "stroke within 6 months before study entry",
                    "criterion": "stroke",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant arrhythmias not controlled by medication. Chronic rate controlled or paroxysmal atrial fibrillation/flutter is not an exclusion to study participation",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant arrhythmias not controlled by medication",
                    "criterion": "clinically significant arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Chronic rate controlled or paroxysmal atrial fibrillation/flutter is not an exclusion",
                    "criterion": "atrial fibrillation/flutter",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "chronic rate controlled",
                                "paroxysmal"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior external beam radiation involving >= 25% of bone marrow or within 14 days of start of protocol therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior external beam radiation involving >= 25% of bone marrow",
                    "criterion": "external beam radiation involving bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior external beam radiation ... within 14 days of start of protocol therapy",
                    "criterion": "external beam radiation",
                    "requirements": [
                        {
                            "requirement_type": "temporal",
                            "expected_value": "within 14 days of start of protocol therapy"
                        },
                        {
                            "requirement_type": "temporal",
                            "expected_value": "prior"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Major surgery within 28 days of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 28 days of study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "*Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.",
            "criterions": [
                {
                    "exact_snippets": "participant received major surgery",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered adequately from the toxicity and/or complications from the intervention",
                    "criterion": "recovery from surgery",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "adequate recovery from toxicity and/or complications"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of human immunodeficiency virus (HIV) (screening not required)",
            "criterions": [
                {
                    "exact_snippets": "Has a known history of human immunodeficiency virus (HIV)",
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection (screening not required)",
            "criterions": [
                {
                    "exact_snippets": "known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)",
                    "criterion": "hepatitis B history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known active hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected)",
                    "criterion": "active hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of active Bacillus tuberculosis (TB)",
            "criterions": [
                {
                    "exact_snippets": "known history of active Bacillus tuberculosis (TB)",
                    "criterion": "active Bacillus tuberculosis (TB)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures",
            "criterions": [
                {
                    "exact_snippets": "Any condition that, in the opinion of the principal investigator, would impair the patient's ability to comply with study procedures",
                    "criterion": "condition impairing compliance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of bleeding diathesis and not currently on anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure",
            "criterions": [
                {
                    "exact_snippets": "History of bleeding diathesis",
                    "criterion": "bleeding diathesis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not currently on anti-coagulation therapy",
                    "criterion": "anti-coagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-coagulation therapy that cannot be safely discontinued for the tumor biopsy procedure",
                    "criterion": "anti-coagulation therapy",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation safety",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Aspartate aminotransferase and alanine aminotransferase =< 2.5 x ULN (<= 5 x ULN in participants with liver metastases)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase ... =< 2.5 x ULN (<= 5 x ULN in participants with liver metastases)",
                    "criterion": "aspartate aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase ... =< 2.5 x ULN (<= 5 x ULN in participants with liver metastases)",
                    "criterion": "alanine aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase and alanine aminotransferase ... (<= 5 x ULN in participants with liver metastases)",
                    "criterion": "aspartate aminotransferase and alanine aminotransferase in participants with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}