{
    "info": {
        "nct_id": "NCT04610372",
        "official_title": "Moderate Versus Ultra Hypofractionation or Brachytherapy for PRimary OligoMetastatic Prostate Cancer Treatment",
        "inclusion_criteria": "* Able to provide informed consent\n* European Cooperative Oncology Group performance status 0 to 2\n* Medically fit for all protocol treatment and follow-up\n* Histologically confirmed adenocarcinoma of the prostate\n* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases\n* No prior therapy for prostate cancer apart from androgen deprivation\n* Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization\n* If used, anti-androgens must have started within 26 weeks of randomization\n* Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)\n* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen & pelvis or MRI abdomen and pelvis, and Bone scan)\n* Planned for long-term androgen deprivation therapy\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* High metastatic burden defined as 5 or more bone metastases or visceral metastases\n* Abnormal liver function\n* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation\n* Medically unfit for anesthesia\n* International Prostate Symptom Score (IPSS) greater than 20\n* Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)\n* Prostate volume greater than 60cc after maximal cytoreduction\n* Pubic arch interference\n* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Able to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* European Cooperative Oncology Group performance status 0 to 2",
            "criterions": [
                {
                    "exact_snippets": "European Cooperative Oncology Group performance status 0 to 2",
                    "criterion": "European Cooperative Oncology Group performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically fit for all protocol treatment and follow-up",
            "criterions": [
                {
                    "exact_snippets": "Medically fit for all protocol treatment and follow-up",
                    "criterion": "medical fitness",
                    "requirements": [
                        {
                            "requirement_type": "fitness for treatment and follow-up",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed adenocarcinoma of the prostate",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Newly diagnosed any Tumor stage, any Nodal stage but with oligo metastases",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed",
                    "criterion": "diagnosis status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "any Tumor stage",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "any Nodal stage",
                    "criterion": "nodal stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "oligo metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "oligo"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior therapy for prostate cancer apart from androgen deprivation",
            "criterions": [
                {
                    "exact_snippets": "No prior therapy for prostate cancer",
                    "criterion": "prior therapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "apart from androgen deprivation",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization",
            "criterions": [
                {
                    "exact_snippets": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must have started within 24 weeks of randomization",
                    "criterion": "Luteinizing Hormone Releasing Hormone (LHRH) agonists or antagonists",
                    "requirements": [
                        {
                            "requirement_type": "start time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "weeks from randomization"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If used, anti-androgens must have started within 26 weeks of randomization",
            "criterions": [
                {
                    "exact_snippets": "anti-androgens must have started within 26 weeks of randomization",
                    "criterion": "anti-androgens",
                    "requirements": [
                        {
                            "requirement_type": "start time relative to randomization",
                            "expected_value": {
                                "operator": "<=",
                                "value": 26,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization (History and physical examination, PSA)",
            "criterions": [
                {
                    "exact_snippets": "Able to complete the necessary investigations prior to and within 12 weeks of starting Androgen Deprivation Therapy (ADT) or of randomization",
                    "criterion": "completion of necessary investigations",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "prior to and within 12 weeks of starting ADT or randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "History and physical examination",
                    "criterion": "history and physical examination",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to complete the necessary investigations priOr to start of Radiotherapy (Transrectal ultrasound-guided biopsy, CT chest, abdomen & pelvis or MRI abdomen and pelvis, and Bone scan)",
            "criterions": [
                {
                    "exact_snippets": "Able to complete the necessary investigations ... Transrectal ultrasound-guided biopsy",
                    "criterion": "transrectal ultrasound-guided biopsy",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to complete the necessary investigations ... CT chest, abdomen & pelvis",
                    "criterion": "CT chest, abdomen & pelvis",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to complete the necessary investigations ... MRI abdomen and pelvis",
                    "criterion": "MRI abdomen and pelvis",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Able to complete the necessary investigations ... Bone scan",
                    "criterion": "bone scan",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planned for long-term androgen deprivation therapy",
            "criterions": [
                {
                    "exact_snippets": "Planned for long-term androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "planned duration",
                            "expected_value": "long-term"
                        }
                    ]
                }
            ]
        },
        {
            "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": "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": "* High metastatic burden defined as 5 or more bone metastases or visceral metastases",
            "criterions": [
                {
                    "exact_snippets": "High metastatic burden defined as 5 or more bone metastases",
                    "criterion": "bone metastases",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "High metastatic burden defined as ... visceral metastases",
                    "criterion": "visceral metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal liver function",
            "criterions": [
                {
                    "exact_snippets": "Abnormal liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "abnormal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindications to EBRT such as active inflammatory bowel disease or previous pelvic radiation",
            "criterions": [
                {
                    "exact_snippets": "Contraindications to EBRT such as active inflammatory bowel disease",
                    "criterion": "inflammatory bowel disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contraindications to EBRT such as ... previous pelvic radiation",
                    "criterion": "previous pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medically unfit for anesthesia",
            "criterions": [
                {
                    "exact_snippets": "Medically unfit for anesthesia",
                    "criterion": "fitness for anesthesia",
                    "requirements": [
                        {
                            "requirement_type": "medical fitness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International Prostate Symptom Score (IPSS) greater than 20",
            "criterions": [
                {
                    "exact_snippets": "International Prostate Symptom Score (IPSS) greater than 20",
                    "criterion": "International Prostate Symptom Score (IPSS)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Restrictive flow pattern with peak flow rate less than10 mL per second or post-void residual greater than 25 per cent of voided volume (when uroflowmetry available)",
            "criterions": [
                {
                    "exact_snippets": "Restrictive flow pattern",
                    "criterion": "flow pattern",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "restrictive"
                        }
                    ]
                },
                {
                    "exact_snippets": "peak flow rate less than10 mL per second",
                    "criterion": "peak flow rate",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "mL per second"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "post-void residual greater than 25 per cent of voided volume",
                    "criterion": "post-void residual",
                    "requirements": [
                        {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "per cent of voided volume"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "when uroflowmetry available",
                    "criterion": "uroflowmetry",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate volume greater than 60cc after maximal cytoreduction",
            "criterions": [
                {
                    "exact_snippets": "Prostate volume greater than 60cc",
                    "criterion": "prostate volume",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "cc"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pubic arch interference",
            "criterions": [
                {
                    "exact_snippets": "Pubic arch interference",
                    "criterion": "pubic arch interference",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
            "criterions": [
                {
                    "exact_snippets": "Transurethral resection of prostate (TURP) within 12 weeks of brachytherapy",
                    "criterion": "transurethral resection of prostate (TURP)",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}