{
    "info": {
        "nct_id": "NCT06202248",
        "official_title": "A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.",
        "inclusion_criteria": "* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1\n* Patient being considered for focal salvage brachytherapy\n* Lesion size ≤ 3 cm in the longest diameter\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds\n* Pre-salvage PSA level (rPSA) below <10 ng/ml\n* Age ≥ 18 years old\n* ECOG Performance Status Scale ≤ 2\n* Subjects' life expectancy is more than 6 months\n* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0\n* Platelet count ≥100,000/mm3\n* Subjects are willing and able to sign an informed consent form.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "* N1 or M1 disease\n* Prior TURP or prostate surgery\n* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)\n* Inability to undergo general or spinal anesthesia\n* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.\n* Previous diagnosis of other malignancy < 3 years of enrollment (excluding non-melanomatous skin cancer)\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT\n* High probability of protocol non-compliance (in opinion of investigator)\n* Subjects not willing to sign an informed consent\n* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed locally recurrent prostate adenocarcinoma cancer",
                    "criterion": "prostate adenocarcinoma cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "recurrence",
                            "expected_value": "locally recurrent"
                        }
                    ]
                },
                {
                    "exact_snippets": "confined to at least 1 hemi-gland",
                    "criterion": "cancer confinement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "at least 1 hemi-gland"
                        }
                    ]
                },
                {
                    "exact_snippets": "concordant pathology and imaging findings",
                    "criterion": "pathology and imaging findings",
                    "requirements": [
                        {
                            "requirement_type": "concordance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months prior to consenting",
                    "criterion": "timeframe for findings",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1",
            "criterions": [
                {
                    "exact_snippets": "Targetable lesion by either PSMA PET-CT according to PERCIST v1.0",
                    "criterion": "targetable lesion by PSMA PET-CT",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "PERCIST v1.0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Targetable lesion ... by multiparametric MRI according RECIST v1.1",
                    "criterion": "targetable lesion by multiparametric MRI",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient being considered for focal salvage brachytherapy",
            "criterions": [
                {
                    "exact_snippets": "Patient being considered for focal salvage brachytherapy",
                    "criterion": "consideration for focal salvage brachytherapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesion size ≤ 3 cm in the longest diameter",
            "criterions": [
                {
                    "exact_snippets": "Lesion size ≤ 3 cm in the longest diameter",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds",
            "criterions": [
                {
                    "exact_snippets": "Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "technical amenability",
                            "expected_value": "full tumor coverage with the Alpha DaRT seeds"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pre-salvage PSA level (rPSA) below <10 ng/ml",
            "criterions": [
                {
                    "exact_snippets": "Pre-salvage PSA level (rPSA) below <10 ng/ml",
                    "criterion": "pre-salvage PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status Scale ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status Scale ≤ 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "scale",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects' life expectancy is more than 6 months",
            "criterions": [
                {
                    "exact_snippets": "Subjects' life expectancy is more than 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0",
            "criterions": [
                {
                    "exact_snippets": "Negative metastatic workup",
                    "criterion": "metastatic workup",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "standard imaging (CT CAP and bone scan)",
                    "criterion": "standard imaging",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "CT CAP",
                                "bone scan"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET",
                    "criterion": "metastatic screening studies",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "multiparametric MRI prostate/whole body",
                                "PSMA PET",
                                "F18 PET",
                                "Axumin PET"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "within 3 months before visit 0",
                    "criterion": "timeframe for imaging",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects are willing and able to sign an informed consent form.",
            "criterions": [
                {
                    "exact_snippets": "willing and able to sign an informed consent form",
                    "criterion": "informed consent",
                    "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* N1 or M1 disease",
            "criterions": [
                {
                    "exact_snippets": "N1",
                    "criterion": "N1 disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "M1 disease",
                    "criterion": "M1 disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)",
            "criterions": [
                {
                    "exact_snippets": "Inability to undergo multiparametric MRI",
                    "criterion": "ability to undergo multiparametric MRI",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "permanent implanted device incompatible with MRI",
                    "criterion": "permanent implanted device compatibility with MRI",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to undergo general or spinal anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Inability to undergo general ... anesthesia",
                    "criterion": "ability to undergo general anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to undergo ... spinal anesthesia",
                    "criterion": "ability to undergo spinal anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.",
            "criterions": [
                {
                    "exact_snippets": "Prior androgen deprivation therapy ... within 3 months before visit 0.",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior ... systemic chemotherapy for prostate cancer within 3 months before visit 0.",
                    "criterion": "systemic chemotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous diagnosis of other malignancy < 3 years of enrollment (excluding non-melanomatous skin cancer)",
            "criterions": [
                {
                    "exact_snippets": "Previous diagnosis of other malignancy < 3 years of enrollment",
                    "criterion": "previous diagnosis of other malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time since diagnosis",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT",
            "criterions": [
                {
                    "exact_snippets": "Volunteers participating in another interventional study in the past 30 days",
                    "criterion": "participation in another interventional study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "which might conflict with the endpoints of this study",
                    "criterion": "conflict with study endpoints",
                    "requirements": [
                        {
                            "requirement_type": "potential conflict",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "or the evaluation of response or toxicity of DaRT",
                    "criterion": "evaluation of response or toxicity of DaRT",
                    "requirements": [
                        {
                            "requirement_type": "potential conflict",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* High probability of protocol non-compliance (in opinion of investigator)",
            "criterions": [
                {
                    "exact_snippets": "High probability of protocol non-compliance",
                    "criterion": "protocol compliance",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects not willing to sign an informed consent",
            "criterions": [
                {
                    "exact_snippets": "not willing to sign an informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)",
            "criterions": [
                {
                    "exact_snippets": "significant comorbidities",
                    "criterion": "comorbidities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "poorly controlled autoimmune diseases",
                    "criterion": "autoimmune diseases",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "poorly controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "vasculitis",
                    "criterion": "vasculitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Prior TURP or prostate surgery",
            "criterions": [
                {
                    "exact_snippets": "Prior TURP",
                    "criterion": "TURP",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior ... prostate surgery",
                    "criterion": "prostate surgery",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}