{
    "info": {
        "nct_id": "NCT05847166",
        "official_title": "A Phase 2/3, Open-Label Study, to Evaluate the Feasibility and Safety of Intravenous [99mTc]Tc-PSMA-T4 in Subjects with Prostate Cancer",
        "inclusion_criteria": "1. 18 years of age or older.\n2. PS ECOG < 2\n3. Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.\n4. Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B.\n5. Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B.\n6. Willingness to participate in this study and to provide written informed consent.\n\nAdditional inclusion criteria for each cohort:\n\nCohort A:\n\n1. Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer\n2. Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients.\n3. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.\n4. No prior treatment for prostate cancer.\n\nCohort B:\n\n1. High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer\n2. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.\n3. No prior treatment for prostate cancer.\n\nCohort C:\n\nBiochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA) OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases (Roach et al.., 2006).\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. No histopathological confirmation of prostate cancer.\n2. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.\n3. Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN.\n4. Renal impairment including eGFR <30 ml / min.\n5. Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis\n6. Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.\n7. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis osteomyelitis.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. 18 years of age or older.",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. PS ECOG < 2",
            "criterions": [
                {
                    "exact_snippets": "PS ECOG < 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above 6.",
            "criterions": [
                {
                    "exact_snippets": "Prior diagnosis of any type of prostate cancer",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score (GlS) above 6",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B.",
            "criterions": [
                {
                    "exact_snippets": "Confirmatory prostate biopsy within 12 weeks",
                    "criterion": "confirmatory prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "only for cohorts A and B",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "A",
                                "B"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B.",
            "criterions": [
                {
                    "exact_snippets": "Pelvic mpMRI prostate with PIRADS 2.1 score",
                    "criterion": "PIRADS score",
                    "requirements": [
                        {
                            "requirement_type": "version",
                            "expected_value": "2.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks before screening",
                    "criterion": "timeframe for MRI",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "only for cohorts A and B",
                    "criterion": "applicable cohorts",
                    "requirements": [
                        {
                            "requirement_type": "applicability",
                            "expected_value": [
                                "A",
                                "B"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer",
            "criterions": [
                {
                    "exact_snippets": "Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer",
                    "criterion": "intermediate risk disease",
                    "requirements": [
                        {
                            "requirement_type": "definition source",
                            "expected_value": "National Comprehensive Cancer Network Guidelines for Prostate Cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients.",
            "criterions": [
                {
                    "exact_snippets": "Greater than 10% chance of lymph node involvement",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "assessed using the Memorial Sloan Kettering nomogram",
                    "criterion": "assessment method for lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "Memorial Sloan Kettering nomogram"
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate cancer patients",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "prostate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.",
            "criterions": [
                {
                    "exact_snippets": "CT of the chest, abdomen and pelvis",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "body parts",
                            "expected_value": [
                                "chest",
                                "abdomen",
                                "pelvis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks before screening",
                    "criterion": "timeframe for scans",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unfavorable risk PC subgroup",
                    "criterion": "risk subgroup",
                    "requirements": [
                        {
                            "requirement_type": "specific subgroup",
                            "expected_value": "unfavorable risk PC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. No prior treatment for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "No prior treatment for prostate cancer",
                    "criterion": "prior treatment for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer",
            "criterions": [
                {
                    "exact_snippets": "High or very high-risk disease",
                    "criterion": "risk level of disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "high",
                                "very high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer",
                    "criterion": "guideline adherence",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": "National Comprehensive Cancer Network Guidelines for Prostate Cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup.",
            "criterions": [
                {
                    "exact_snippets": "CT of the chest, abdomen and pelvis",
                    "criterion": "CT scan",
                    "requirements": [
                        {
                            "requirement_type": "body parts",
                            "expected_value": [
                                "chest",
                                "abdomen",
                                "pelvis"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 12 weeks before screening",
                    "criterion": "timeframe for scans",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unfavorable risk PC subgroup",
                    "criterion": "risk subgroup",
                    "requirements": [
                        {
                            "requirement_type": "specific subgroup",
                            "expected_value": "unfavorable risk PC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No prior treatment for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "No prior treatment for prostate cancer",
                    "criterion": "prior treatment for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA) OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases (Roach et al.., 2006).",
            "criterions": [
                {
                    "exact_snippets": "Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence)",
                    "criterion": "PSA persistence after radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "PSA level",
                            "expected_value": "failure to fall to undetectable levels"
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable PSA after radical prostatectomy with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence)",
                    "criterion": "PSA recurrence after radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "PSA level",
                            "expected_value": "subsequent detectable PSA that increases on 2 or more determinations"
                        }
                    ]
                },
                {
                    "exact_snippets": "biochemical failure after definitive radiotherapy based on Phoenix Consensus (a rise by 2 ng/mL or more above the nadir PSA)",
                    "criterion": "biochemical failure after definitive radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "PSA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic evidence of metastatic disease without PSA persistence/recurrence",
                    "criterion": "radiographic evidence of metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "PSA persistence/recurrence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms suggesting distant metastases",
                    "criterion": "clinical symptoms suggesting distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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": "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. No histopathological confirmation of prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "No histopathological confirmation of prostate cancer.",
                    "criterion": "histopathological confirmation of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "pacemakers",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metal parts that prevent pelvic MRI",
                    "criterion": "metal parts preventing pelvic MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "confirm the presence of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN.",
            "criterions": [
                {
                    "exact_snippets": "Abnormal liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN)",
                    "criterion": "liver enzymes",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "increase in bilirubin greater than 2x ULN",
                    "criterion": "bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "increase",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Renal impairment including eGFR <30 ml / min.",
            "criterions": [
                {
                    "exact_snippets": "Renal impairment",
                    "criterion": "renal impairment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "eGFR <30 ml / min",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis",
            "criterions": [
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... other cardiac events requiring hospitalization (unstable angina, etc.)",
                    "criterion": "other cardiac events requiring hospitalization",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... acute stroke",
                    "criterion": "acute stroke",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                },
                {
                    "exact_snippets": "Within 6 months before inclusion into the study: ... deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before inclusion"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block.",
            "criterions": [
                {
                    "exact_snippets": "Acute congestive heart failure",
                    "criterion": "acute congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "severe arrhythmia",
                    "criterion": "severe arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "second or higher degree atrio-ventricular (AV) heart block",
                    "criterion": "second or higher degree atrio-ventricular (AV) heart block",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis osteomyelitis.",
            "criterions": [
                {
                    "exact_snippets": "An active infection that the investigator deems sufficient to exclude the patient from the study",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficient to exclude the patient from the study"
                        }
                    ]
                },
                {
                    "exact_snippets": "urinary tract infections",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "respiratory tract infections",
                    "criterion": "respiratory tract infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "diabetic foot infections with osteomyelitis",
                    "criterion": "diabetic foot infection with osteomyelitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "6. Willingness to participate in this study and to provide written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Willingness to participate in this study",
                    "criterion": "willingness to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness ... to provide written informed consent",
                    "criterion": "willingness to provide written informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Additional inclusion criteria for each cohort:",
            "criterions": []
        },
        {
            "line": "Cohort A:",
            "criterions": []
        },
        {
            "line": "Cohort B:",
            "criterions": []
        },
        {
            "line": "Cohort C:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}