{
    "info": {
        "nct_id": "NCT06546527",
        "official_title": "A Clinical Study Evaluating the Pharmacokinetics, Safety, Tolerability, and Efficacy of [177Lu]Lu-PSMA-137 in Metastatic Castration Resistant Prostate Cancer（mCRPC）",
        "inclusion_criteria": "* Before initiating any assessment process, written informed consent must be obtained from the subject.\n* The participant must be an adult male aged 18 years or older, with an expected lifespan of more than 6 months.\n* The participant must have a confirmed diagnosis of prostate cancer based on histological, pathological, and/or cytological examination.\n* The participant 's [18F]F-PSMA-137 positron emission tomography/computed tomography (PET/CT) scan results must be positive, specifically defined as the presence of prostate specific membrane antigen (PSMA) positive lesions or metastatic lesions with tumor PSMA expression higher than liver parenchyma; no PSMA-negative metastatic lesions: presence of lymph node metastatic lesions with a short diameter of no less than 2.5cm and PSMA concentration lower than liver parenchyma; presence of soft tissue metastatic lesions with a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma; presence of metastatic bone lesions invading soft tissue, with the soft tissue having a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma.\n* The participant's serum/plasma testosterone level must be maintained below the castrate level (i.e., <50 ng/dL or <1.7 nmol/L).\n* The participant must have received at least one androgen receptor pathway inhibitors(ARPI) (such as enzalutamide and/or abiraterone) treatment and experienced treatment failure.\n* The participant must have received at least one but no more than two taxane-based drug treatment regimens and experienced treatment failure; a taxane-based drug treatment regimen is defined as exposure to at least two cycles of taxane drugs. If the participant has only received one taxane-based drug treatment regimen and their doctor assesses that they are unsuitable for a second taxane-based drug treatment regimen due to reasons such as frailty or intolerance, the subject may still be included in the study.\n* The records confirm the progressive mCRPC based on at least one of the following criteria:Serum/plasma prostate specific antigen (PSA) progression is defined as an increase in PSA levels measured in two separate instances at least one week apart, with a minimum starting value of 2.0 ng/mL.Soft tissue progression according to the modified response evaluation criteria in solid tumors version version 1.1 by prostate cancer working group 3 (PCWG3) (Eisenhauer et al., 2009; Scher et al., 2016).Bone disease progression: the presence of two new bone lesions; bone scan positivity alone defines metastatic disease to bone [PCWG3 criteria (Scher et al., 2016)].\n* Prior to enrollment, participant must have had baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within ≤ 21 days, indicating the presence of ≥ 1 metastatic lesion, with at least one measurable lesion as determined by the modified RECIST version 1.1 by PCWG3.\n* Participant must have adequate organ function, including:Bone marrow reserve: white blood cell (WBC) count ≥ 2.5×109/L or absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.Liver: total bilirubin ≤ 1.5× the upper limit of normal (ULN). For subjects with known Gilbert's syndrome, ≤ 3× ULN is acceptable; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0× ULN or ≤ 5.0× ULN for subjects with liver metastases.\n\nKidney: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) formula.Albumin level: > 3.0 g/dL.\n\n* ECOG (Eastern Cooperative Oncology Group) performance status score must be 0 - 2.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Within 6 months prior to enrollment, participant who have received radionuclide therapy such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemibody radiotherapy;\n* Participant who have previously received PSMA-targeted radioligand therapy;\n* Participant who require radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments within 28 days prior to enrollment or during the trial;\n* Participant who have participated in any other clinical trial within 28 days prior to enrollment;\n* Participant with a history of hypersensitivity to any study drug, its excipients, or drugs of similar chemical classes;\n* Participant with a history of central nervous system (CNS) metastases, neurological instability, symptoms, or requiring glucocorticoids to maintain neurological stability; however, participant with CNS metastases who have received treatment (surgery, radiotherapy, gamma knife, etc.), are asymptomatic with stable neurological function, and are not using corticosteroids are eligible to participate in the study; participant with epidural disease, spinal canal disease, and previously treated areas of spinal cord involvement that are stable and without neurological impairment are also allowed;\n* Participant with super-bone imaging observed on baseline bone scans;\n* Symptomatic spinal cord compression or clinical or radiological findings suggestive of impending spinal cord compression; A history or current diagnosis of the following electrocardiogram (ECG) abnormalities, indicating significant safety risks for the participant: clinically significant arrhythmias such as sustained ventricular tachycardia, complete left bundle branch block, high-degree atrioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree atrioventricular block); cardiac or cardiac repolarization abnormalities, including any of the following: a history of myocardial infarction (MI), angina, or coronary artery - bypass grafting (CABG) within 6 months prior to signing the informed consent form (ICF);\n* Accompanied by severe (as determined by the principal investigator) medical conditions, including but not limited to new york heart association class III or IV congestive heart failure, a history of congenital long QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant illnesses that the investigator believes may affect study participation or compliance; subjects with human immunodeficiency virus (HIV) infection at low risk for acquiredImmune deficiency syndrome，(AIDS) related outcomes may participate in this trial;\n* A diagnosis of other malignancies that may alter life expectancy or potentially interfere with disease assessment. Participant with a prior history of malignancy before enrollment, but who have received adequate treatment and have been disease-free and treatment-free for more than 3 years, are eligible to participate in the study, as are participant with adequately treated non-melanoma skin cancer and superficial bladder cancer.\n* Sexually active men were unwilling to use condoms during sexual intercourse during the study treatment period and within 14 weeks after stopping the study treatment. All sexually active male participant must use condoms to prevent their partners from getting pregnant and prevent the transmission of study treatment drugs to their partners through semen. In addition, male participant must not donate sperm within the above-mentioned time frame;\n* With uncontrollable bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence are eligible to participate in the study if they can be controlled through the best available standard treatments (including urine pads and drainage);\n* History of physical or mental illness/condition that may interfere with the purpose and evaluation of the study;\n* Any condition that prevents the participant from assuming an arm-raising position.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Before initiating any assessment process, written informed consent must be obtained from the subject.",
            "criterions": [
                {
                    "exact_snippets": "written informed consent must be obtained",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant must be an adult male aged 18 years or older, with an expected lifespan of more than 6 months.",
            "criterions": [
                {
                    "exact_snippets": "adult male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged 18 years or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected lifespan of more than 6 months",
                    "criterion": "expected lifespan",
                    "requirements": [
                        {
                            "requirement_type": "minimum duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant must have a confirmed diagnosis of prostate cancer based on histological, pathological, and/or cytological examination.",
            "criterions": [
                {
                    "exact_snippets": "confirmed diagnosis of prostate cancer",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "based on histological, pathological, and/or cytological examination",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "histological",
                                "pathological",
                                "cytological"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant 's [18F]F-PSMA-137 positron emission tomography/computed tomography (PET/CT) scan results must be positive, specifically defined as the presence of prostate specific membrane antigen (PSMA) positive lesions or metastatic lesions with tumor PSMA expression higher than liver parenchyma; no PSMA-negative metastatic lesions: presence of lymph node metastatic lesions with a short diameter of no less than 2.5cm and PSMA concentration lower than liver parenchyma; presence of soft tissue metastatic lesions with a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma; presence of metastatic bone lesions invading soft tissue, with the soft tissue having a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma.",
            "criterions": [
                {
                    "exact_snippets": "[18F]F-PSMA-137 positron emission tomography/computed tomography (PET/CT) scan results must be positive",
                    "criterion": "[18F]F-PSMA-137 PET/CT scan results",
                    "requirements": [
                        {
                            "requirement_type": "positivity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of prostate specific membrane antigen (PSMA) positive lesions",
                    "criterion": "PSMA positive lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic lesions with tumor PSMA expression higher than liver parenchyma",
                    "criterion": "metastatic lesions with tumor PSMA expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "liver parenchyma"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no PSMA-negative metastatic lesions",
                    "criterion": "PSMA-negative metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of lymph node metastatic lesions with a short diameter of no less than 2.5cm and PSMA concentration lower than liver parenchyma",
                    "criterion": "lymph node metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "short diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "PSMA concentration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "liver parenchyma"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of soft tissue metastatic lesions with a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma",
                    "criterion": "soft tissue metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "short diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "PSMA concentration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "liver parenchyma"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "presence of metastatic bone lesions invading soft tissue, with the soft tissue having a short diameter of no less than 1cm and PSMA concentration lower than liver parenchyma",
                    "criterion": "metastatic bone lesions invading soft tissue",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "soft tissue short diameter",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm"
                            }
                        },
                        {
                            "requirement_type": "PSMA concentration",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "liver parenchyma"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant's serum/plasma testosterone level must be maintained below the castrate level (i.e., <50 ng/dL or <1.7 nmol/L).",
            "criterions": [
                {
                    "exact_snippets": "serum/plasma testosterone level ... <50 ng/dL or <1.7 nmol/L",
                    "criterion": "serum/plasma testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 50,
                                        "unit": "ng/dL"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 1.7,
                                        "unit": "nmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant must have received at least one androgen receptor pathway inhibitors(ARPI) (such as enzalutamide and/or abiraterone) treatment and experienced treatment failure.",
            "criterions": [
                {
                    "exact_snippets": "received at least one androgen receptor pathway inhibitors(ARPI) (such as enzalutamide and/or abiraterone) treatment",
                    "criterion": "androgen receptor pathway inhibitors treatment",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "treatment"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced treatment failure",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The participant must have received at least one but no more than two taxane-based drug treatment regimens and experienced treatment failure; a taxane-based drug treatment regimen is defined as exposure to at least two cycles of taxane drugs. If the participant has only received one taxane-based drug treatment regimen and their doctor assesses that they are unsuitable for a second taxane-based drug treatment regimen due to reasons such as frailty or intolerance, the subject may still be included in the study.",
            "criterions": [
                {
                    "exact_snippets": "received at least one but no more than two taxane-based drug treatment regimens",
                    "criterion": "taxane-based drug treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced treatment failure",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exposure to at least two cycles of taxane drugs",
                    "criterion": "cycles of taxane drugs",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "doctor assesses that they are unsuitable for a second taxane-based drug treatment regimen due to reasons such as frailty or intolerance",
                    "criterion": "unsuitability for a second taxane-based drug treatment regimen",
                    "requirements": [
                        {
                            "requirement_type": "reason",
                            "expected_value": [
                                "frailty",
                                "intolerance"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The records confirm the progressive mCRPC based on at least one of the following criteria:Serum/plasma prostate specific antigen (PSA) progression is defined as an increase in PSA levels measured in two separate instances at least one week apart, with a minimum starting value of 2.0 ng/mL.Soft tissue progression according to the modified response evaluation criteria in solid tumors version version 1.1 by prostate cancer working group 3 (PCWG3) (Eisenhauer et al., 2009; Scher et al., 2016).Bone disease progression: the presence of two new bone lesions; bone scan positivity alone defines metastatic disease to bone [PCWG3 criteria (Scher et al., 2016)].",
            "criterions": [
                {
                    "exact_snippets": "Serum/plasma prostate specific antigen (PSA) progression ... increase in PSA levels ... minimum starting value of 2.0 ng/mL.",
                    "criterion": "PSA progression",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurement instances",
                            "expected_value": ">= 2"
                        },
                        {
                            "requirement_type": "time interval",
                            "expected_value": ">= 1 week"
                        },
                        {
                            "requirement_type": "starting value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Soft tissue progression according to the modified response evaluation criteria in solid tumors version version 1.1 by prostate cancer working group 3 (PCWG3)",
                    "criterion": "soft tissue progression",
                    "requirements": [
                        {
                            "requirement_type": "evaluation criteria",
                            "expected_value": "modified response evaluation criteria in solid tumors version 1.1 by PCWG3"
                        }
                    ]
                },
                {
                    "exact_snippets": "Bone disease progression: the presence of two new bone lesions; bone scan positivity alone defines metastatic disease to bone [PCWG3 criteria",
                    "criterion": "bone disease progression",
                    "requirements": [
                        {
                            "requirement_type": "new bone lesions",
                            "expected_value": ">= 2"
                        },
                        {
                            "requirement_type": "bone scan positivity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior to enrollment, participant must have had baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within ≤ 21 days, indicating the presence of ≥ 1 metastatic lesion, with at least one measurable lesion as determined by the modified RECIST version 1.1 by PCWG3.",
            "criterions": [
                {
                    "exact_snippets": "baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained within ≤ 21 days",
                    "criterion": "baseline imaging",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "computed tomography (CT)",
                                "magnetic resonance imaging (MRI)",
                                "bone scan"
                            ]
                        },
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "indicating the presence of ≥ 1 metastatic lesion",
                    "criterion": "metastatic lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one measurable lesion as determined by the modified RECIST version 1.1 by PCWG3",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "modified RECIST version 1.1 by PCWG3"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant must have adequate organ function, including:Bone marrow reserve: white blood cell (WBC) count ≥ 2.5×109/L or absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 100×109/L, and hemoglobin ≥ 9 g/dL.Liver: total bilirubin ≤ 1.5× the upper limit of normal (ULN). For subjects with known Gilbert's syndrome, ≤ 3× ULN is acceptable; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0× ULN or ≤ 5.0× ULN for subjects with liver metastases.",
            "criterions": [
                {
                    "exact_snippets": "white blood cell (WBC) count ≥ 2.5×109/L",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absolute neutrophil count (ANC) ≥ 1.5×109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count ≥ 100×109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "×109/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hemoglobin ≥ 9 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "total bilirubin ≤ 1.5× the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "For subjects with known Gilbert's syndrome, ≤ 3× ULN is acceptable",
                    "criterion": "total bilirubin in subjects with Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0× ULN",
                    "criterion": "alanine aminotransferase or aspartate aminotransferase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ... ≤ 5.0× ULN for subjects with liver metastases",
                    "criterion": "alanine aminotransferase or aspartate aminotransferase in subjects with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5.0,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Kidney: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) formula.Albumin level: > 3.0 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Kidney: estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2",
                    "criterion": "estimated glomerular filtration rate (eGFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min/1.73 m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Albumin level: > 3.0 g/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG (Eastern Cooperative Oncology Group) performance status score must be 0 - 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG (Eastern Cooperative Oncology Group) performance status score must be 0 - 2.",
                    "criterion": "ECOG performance status score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Within 6 months prior to enrollment, participant who have received radionuclide therapy such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemibody radiotherapy;",
            "criterions": [
                {
                    "exact_snippets": "Within 6 months prior to enrollment, participant who have received radionuclide therapy such as strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemibody radiotherapy",
                    "criterion": "radionuclide therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months prior to enrollment"
                        },
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "strontium-89",
                                "samarium-153",
                                "rhenium-186",
                                "rhenium-188",
                                "radium-223",
                                "hemibody radiotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant who have previously received PSMA-targeted radioligand therapy;",
            "criterions": [
                {
                    "exact_snippets": "previously received PSMA-targeted radioligand therapy",
                    "criterion": "PSMA-targeted radioligand therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant who require radiotherapy, chemotherapy, immunotherapy, or other anti-tumor treatments within 28 days prior to enrollment or during the trial;",
            "criterions": [
                {
                    "exact_snippets": "require radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "require ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "require ... immunotherapy",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "require ... other anti-tumor treatments",
                    "criterion": "other anti-tumor treatments",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant who have participated in any other clinical trial within 28 days prior to enrollment;",
            "criterions": [
                {
                    "exact_snippets": "participated in any other clinical trial within 28 days prior to enrollment",
                    "criterion": "participation in other clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "time since last participation",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with a history of hypersensitivity to any study drug, its excipients, or drugs of similar chemical classes;",
            "criterions": [
                {
                    "exact_snippets": "history of hypersensitivity to any study drug",
                    "criterion": "hypersensitivity to study drug",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... its excipients",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... drugs of similar chemical classes",
                    "criterion": "hypersensitivity to drugs of similar chemical classes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with a history of central nervous system (CNS) metastases, neurological instability, symptoms, or requiring glucocorticoids to maintain neurological stability; however, participant with CNS metastases who have received treatment (surgery, radiotherapy, gamma knife, etc.), are asymptomatic with stable neurological function, and are not using corticosteroids are eligible to participate in the study; participant with epidural disease, spinal canal disease, and previously treated areas of spinal cord involvement that are stable and without neurological impairment are also allowed;",
            "criterions": [
                {
                    "exact_snippets": "history of central nervous system (CNS) metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neurological instability",
                    "criterion": "neurological instability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptoms",
                    "criterion": "neurological symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring glucocorticoids to maintain neurological stability",
                    "criterion": "glucocorticoid requirement for neurological stability",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CNS metastases who have received treatment (surgery, radiotherapy, gamma knife, etc.)",
                    "criterion": "CNS metastases treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "surgery",
                                "radiotherapy",
                                "gamma knife"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "asymptomatic with stable neurological function",
                    "criterion": "neurological function",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not using corticosteroids",
                    "criterion": "corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "epidural disease",
                    "criterion": "epidural disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal canal disease",
                    "criterion": "spinal canal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previously treated areas of spinal cord involvement that are stable and without neurological impairment",
                    "criterion": "spinal cord involvement",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "neurological impairment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant with super-bone imaging observed on baseline bone scans;",
            "criterions": [
                {
                    "exact_snippets": "super-bone imaging observed on baseline bone scans",
                    "criterion": "super-bone imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic spinal cord compression or clinical or radiological findings suggestive of impending spinal cord compression; A history or current diagnosis of the following electrocardiogram (ECG) abnormalities, indicating significant safety risks for the participant: clinically significant arrhythmias such as sustained ventricular tachycardia, complete left bundle branch block, high-degree atrioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree atrioventricular block); cardiac or cardiac repolarization abnormalities, including any of the following: a history of myocardial infarction (MI), angina, or coronary artery - bypass grafting (CABG) within 6 months prior to signing the informed consent form (ICF);",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical or radiological findings suggestive of impending spinal cord compression",
                    "criterion": "impending spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "suggestive findings",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history or current diagnosis of the following electrocardiogram (ECG) abnormalities",
                    "criterion": "ECG abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "history or current diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant arrhythmias such as sustained ventricular tachycardia",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "complete left bundle branch block",
                    "criterion": "left bundle branch block",
                    "requirements": [
                        {
                            "requirement_type": "completeness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high-degree atrioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree atrioventricular block)",
                    "criterion": "atrioventricular block",
                    "requirements": [
                        {
                            "requirement_type": "high-degree",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac or cardiac repolarization abnormalities",
                    "criterion": "cardiac repolarization abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a history of myocardial infarction (MI)",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "coronary artery - bypass grafting (CABG) within 6 months prior to signing the informed consent form (ICF)",
                    "criterion": "coronary artery bypass grafting",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Accompanied by severe (as determined by the principal investigator) medical conditions, including but not limited to new york heart association class III or IV congestive heart failure, a history of congenital long QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant illnesses that the investigator believes may affect study participation or compliance; subjects with human immunodeficiency virus (HIV) infection at low risk for acquiredImmune deficiency syndrome，(AIDS) related outcomes may participate in this trial;",
            "criterions": [
                {
                    "exact_snippets": "severe (as determined by the principal investigator) medical conditions",
                    "criterion": "severe medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "new york heart association class III or IV congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "New York Heart Association class III",
                                "New York Heart Association class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "known active hepatitis B or C",
                    "criterion": "hepatitis B or C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant illnesses that the investigator believes may affect study participation or compliance",
                    "criterion": "significant illnesses",
                    "requirements": [
                        {
                            "requirement_type": "impact on study",
                            "expected_value": "may affect participation or compliance"
                        }
                    ]
                },
                {
                    "exact_snippets": "human immunodeficiency virus (HIV) infection at low risk for acquiredImmune deficiency syndrome，(AIDS) related outcomes",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "risk for AIDS related outcomes",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A diagnosis of other malignancies that may alter life expectancy or potentially interfere with disease assessment. Participant with a prior history of malignancy before enrollment, but who have received adequate treatment and have been disease-free and treatment-free for more than 3 years, are eligible to participate in the study, as are participant with adequately treated non-melanoma skin cancer and superficial bladder cancer.",
            "criterions": [
                {
                    "exact_snippets": "A diagnosis of other malignancies that may alter life expectancy or potentially interfere with disease assessment.",
                    "criterion": "other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "impact on life expectancy",
                            "expected_value": "may alter"
                        },
                        {
                            "requirement_type": "interference with disease assessment",
                            "expected_value": "potentially interfere"
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant with a prior history of malignancy before enrollment, but who have received adequate treatment and have been disease-free and treatment-free for more than 3 years, are eligible",
                    "criterion": "prior history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequate treatment"
                        },
                        {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "treatment-free duration",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "participant with adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "participant with ... superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sexually active men were unwilling to use condoms during sexual intercourse during the study treatment period and within 14 weeks after stopping the study treatment. All sexually active male participant must use condoms to prevent their partners from getting pregnant and prevent the transmission of study treatment drugs to their partners through semen. In addition, male participant must not donate sperm within the above-mentioned time frame;",
            "criterions": [
                {
                    "exact_snippets": "Sexually active men were unwilling to use condoms during sexual intercourse during the study treatment period and within 14 weeks after stopping the study treatment.",
                    "criterion": "use of condoms",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "male participant must not donate sperm within the above-mentioned time frame",
                    "criterion": "sperm donation",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With uncontrollable bladder outflow obstruction or urinary incontinence. Note: Participant with bladder outflow obstruction or urinary incontinence are eligible to participate in the study if they can be controlled through the best available standard treatments (including urine pads and drainage);",
            "criterions": [
                {
                    "exact_snippets": "uncontrollable bladder outflow obstruction",
                    "criterion": "bladder outflow obstruction",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable ... urinary incontinence",
                    "criterion": "urinary incontinence",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of physical or mental illness/condition that may interfere with the purpose and evaluation of the study;",
            "criterions": [
                {
                    "exact_snippets": "History of physical or mental illness/condition",
                    "criterion": "physical or mental illness/condition",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "interference with the purpose and evaluation of the study",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any condition that prevents the participant from assuming an arm-raising position.",
            "criterions": [
                {
                    "exact_snippets": "condition that prevents the participant from assuming an arm-raising position",
                    "criterion": "ability to assume an arm-raising position",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}