{
    "info": {
        "nct_id": "NCT04642027",
        "official_title": "PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer",
        "inclusion_criteria": "* Patients with prostate adenocarcinoma treated with radical prostatectomy;\n* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;\n* No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days) without evidence of lymph node or distant metastases;\n* PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;\n* PSA at inclusion < 1.0 ng/mL;\n* WHO performance status 0-2 at inclusion;\n* Age at inclusion between 18 and 80 years;\n* Written (signed and dated) informed consent prior to registration.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;\n* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;\n* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;\n* Double-sided metallic hip prosthesis;\n* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with prostate adenocarcinoma treated with radical prostatectomy;",
            "criterions": [
                {
                    "exact_snippets": "prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with radical prostatectomy",
                    "criterion": "treatment with radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;",
            "criterions": [
                {
                    "exact_snippets": "Tumour stage pT2-4",
                    "criterion": "tumour stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "pT"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "pT"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "R0-1",
                    "criterion": "resection margin status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "R"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "R"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pN0",
                    "criterion": "pathological lymph node status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pN0"
                        }
                    ]
                },
                {
                    "exact_snippets": "cN0, cNx",
                    "criterion": "clinical lymph node status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "cN0",
                                "cNx"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score available",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No lymph node or distant metastases. A recent PSMA-PET scan (< 60 days) without evidence of lymph node or distant metastases;",
            "criterions": [
                {
                    "exact_snippets": "No lymph node ... without evidence of lymph node",
                    "criterion": "lymph node metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No ... distant metastases ... without evidence of ... distant metastases",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A recent PSMA-PET scan (< 60 days)",
                    "criterion": "PSMA-PET scan",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;",
            "criterions": [
                {
                    "exact_snippets": "PSA progression after prostatectomy defined as two consecutive rises with the final PSA > 0.1 ng/mL",
                    "criterion": "PSA progression",
                    "requirements": [
                        {
                            "requirement_type": "pattern",
                            "expected_value": "two consecutive rises"
                        },
                        {
                            "requirement_type": "final PSA level",
                            "expected_value": {
                                "operator": ">",
                                "value": 0.1,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA progression after prostatectomy defined as ... 3 consecutive rises",
                    "criterion": "PSA progression",
                    "requirements": [
                        {
                            "requirement_type": "pattern",
                            "expected_value": "3 consecutive rises"
                        }
                    ]
                },
                {
                    "exact_snippets": "The first value must be measured at least 6 weeks after radical prostatectomy",
                    "criterion": "PSA measurement timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "at least 6 weeks after radical prostatectomy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA at inclusion < 1.0 ng/mL;",
            "criterions": [
                {
                    "exact_snippets": "PSA at inclusion < 1.0 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.0,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status 0-2 at inclusion;",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status 0-2",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age at inclusion between 18 and 80 years;",
            "criterions": [
                {
                    "exact_snippets": "Age at inclusion between 18 and 80 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written (signed and dated) informed consent prior to registration.",
            "criterions": [
                {
                    "exact_snippets": "Written (signed and dated) informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "format",
                            "expected_value": [
                                "written",
                                "signed",
                                "dated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;",
            "criterions": [
                {
                    "exact_snippets": "Prior pelvic irradiation",
                    "criterion": "pelvic irradiation",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(chemo)hormonal therapy",
                    "criterion": "(chemo)hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "orchiectomy",
                    "criterion": "orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;",
            "criterions": [
                {
                    "exact_snippets": "Previous or concurrent active invasive cancers",
                    "criterion": "active invasive cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other than superficial non-melanoma skin cancers",
                    "criterion": "superficial non-melanoma skin cancers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET/CT scan, 60 days prior to registration;",
            "criterions": [
                {
                    "exact_snippets": "Patients with positive nodes",
                    "criterion": "lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "distant metastases based on the surgical specimen of lymphadenectomy",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSMA-PET/CT scan, 60 days prior to registration",
                    "criterion": "PSMA-PET/CT scan",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Double-sided metallic hip prosthesis;",
            "criterions": [
                {
                    "exact_snippets": "Double-sided metallic hip prosthesis",
                    "criterion": "hip prosthesis",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "double-sided metallic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.",
            "criterions": [
                {
                    "exact_snippets": "Inability or unwillingness to understand the information on trial-related topics",
                    "criterion": "understanding of trial-related topics",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness ... to give informed consent",
                    "criterion": "ability to give informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability or unwillingness ... to fill out QoL questionnaires",
                    "criterion": "ability to fill out QoL questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}