{
    "info": {
        "nct_id": "NCT05847348",
        "official_title": "A Prospective, Open-Label, Single-Arm, Multi-center Study to Evaluate the Diagnostic Efficacy and Safety of 68Ga-PSMA-11 PET/CT or PET/MRI in Patients With Biochemical Recurrent Prostate Cancer",
        "inclusion_criteria": "1. Are able to understand and provide written informed consent document.\n2. Are Chinese males aged ≥ 18 years.\n3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).\n\n   1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP\n   2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;\n4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).\n5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.\n6. Are willing and able to comply with scheduled\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.\n2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.\n3. Are participating or plan to participate in any drug or device clinical study during the study period.\n4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.\n5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.\n6. Have prior history of salivary gland disease or Paget's disease.\n7. Have a history of fracture and anemia within the last year.\n8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.\n9. Is deemed not suitable for participating in this trial in the opinion of the investigator.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Are able to understand and provide written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "able to understand and provide written informed consent document",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Are Chinese males aged ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Chinese males",
                    "criterion": "ethnicity and gender",
                    "requirements": [
                        {
                            "requirement_type": "ethnicity",
                            "expected_value": "Chinese"
                        },
                        {
                            "requirement_type": "gender",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Have histopathologically confirmed prostate adenocarcinoma and have undergone radical prostatectomy and/or radical radiotherapy and experienced biochemical recurrence (PSA should be measured within 30 days of screening).",
            "criterions": [
                {
                    "exact_snippets": "histopathologically confirmed prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone radical prostatectomy and/or radical radiotherapy",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "treatments",
                            "expected_value": [
                                "radical prostatectomy",
                                "radical radiotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "experienced biochemical recurrence",
                    "criterion": "biochemical recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA should be measured within 30 days of screening",
                    "criterion": "PSA measurement",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 30 days of screening"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Post radical prostatectomy (RP) PSA ≥0.2 ng/mL measured 6 weeks after RP",
            "criterions": [
                {
                    "exact_snippets": "Post radical prostatectomy (RP) PSA ≥0.2 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "measurement time",
                            "expected_value": "6 weeks after RP"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA;",
            "criterions": [
                {
                    "exact_snippets": "Post radiation therapy - ASTRO-Phoenix consensus definition Nadir + ≥ 2 ng/mL rise in PSA",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "post-radiation therapy status",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "rise",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have a Karnofsky performance status ≥ 60 (or ECOG/WHO equivalent).",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status ≥ 60",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG/WHO equivalent",
                    "criterion": "ECOG/WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "performance status",
                            "expected_value": "equivalent to Karnofsky ≥ 60"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Agree to practice a highly effective method of contraception for at least 28 days after 68Ga-PSMA-11 administration.",
            "criterions": [
                {
                    "exact_snippets": "Agree to practice a highly effective method of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 28 days after 68Ga-PSMA-11 administration",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Are willing and able to comply with scheduled",
            "criterions": [
                {
                    "exact_snippets": "willing and able to comply with scheduled",
                    "criterion": "compliance with scheduled activities",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Have a prior history of any other malignancy within the last year, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.",
            "criterions": [
                {
                    "exact_snippets": "prior history of any other malignancy within the last year",
                    "criterion": "prior history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last year"
                        }
                    ]
                },
                {
                    "exact_snippets": "other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized",
                    "criterion": "skin basal cell or cutaneous superficial squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Have prior use of radionuclides with an interval of less than 10 physical half-lives before the administration of 68Ga-PSMA-11.",
            "criterions": [
                {
                    "exact_snippets": "prior use of radionuclides",
                    "criterion": "prior use of radionuclides",
                    "requirements": [
                        {
                            "requirement_type": "interval",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "physical half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Are participating or plan to participate in any drug or device clinical study during the study period.",
            "criterions": [
                {
                    "exact_snippets": "participating or plan to participate in any drug or device clinical study",
                    "criterion": "participation in other clinical studies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Have a known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11.",
            "criterions": [
                {
                    "exact_snippets": "known hypersensitivity to the active ingredient or its components of 68Ga-PSMA-11",
                    "criterion": "hypersensitivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Cannot lie flat or remain still while a PET scan is being performed or cannot tolerate a PET scan.",
            "criterions": [
                {
                    "exact_snippets": "Cannot lie flat or remain still while a PET scan is being performed",
                    "criterion": "ability to lie flat or remain still during PET scan",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot tolerate a PET scan",
                    "criterion": "tolerance of PET scan",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Have prior history of salivary gland disease or Paget's disease.",
            "criterions": [
                {
                    "exact_snippets": "prior history of salivary gland disease",
                    "criterion": "salivary gland disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior history of ... Paget's disease",
                    "criterion": "Paget's disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Have a history of fracture and anemia within the last year.",
            "criterions": [
                {
                    "exact_snippets": "history of fracture",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia within the last year",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have abnormalities in physical examination, ECG, and protocol-specified clinical laboratory tests during the Screening Period that, in the judgment of the investigator, could affect safety or compliance.",
            "criterions": [
                {
                    "exact_snippets": "abnormalities in physical examination",
                    "criterion": "physical examination",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormalities in ... ECG",
                    "criterion": "ECG",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormalities in ... protocol-specified clinical laboratory tests",
                    "criterion": "protocol-specified clinical laboratory tests",
                    "requirements": [
                        {
                            "requirement_type": "abnormalities",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Is deemed not suitable for participating in this trial in the opinion of the investigator.",
            "criterions": [
                {
                    "exact_snippets": "deemed not suitable for participating in this trial in the opinion of the investigator",
                    "criterion": "suitability for trial participation",
                    "requirements": [
                        {
                            "requirement_type": "opinion",
                            "expected_value": "investigator's discretion"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}