{
    "info": {
        "nct_id": "NCT02542501",
        "official_title": "A Prospective Post Marketing Non Interventional Study to Evaluate the Presence of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Scheduled to Receive LHRH Analogues and to Evaluate the Effect of LHRH Analogues on Lower Urinary Tract Symptoms (ANALUTS Study)",
        "inclusion_criteria": "* Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.\n* Patients having provided written informed consent\n* Patients mentally fit for completing a self-administered questionnaire\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Any surgical or radiotherapy treatment performed at prostate level before the entry of the study\n* Patient with castrate levels of testosterone ( < 50 ng/dL) at his first IPSS questionnaire\n* Patients who are also participating in any other clinical study within the last 2 months before study entry\n* Life expectancy of less than 12 months",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adult men with locally advanced or metastatic prostate cancer scheduled to receive LHRH analogues. A patient who has completed an IPSS questionnaire in his last visit, before the start of LHRH analogues, will be able to participate in the study. This last visit has to be done 6 months before the baseline visit.",
            "criterions": [
                {
                    "exact_snippets": "Adult men",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected gender",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "Adult men",
                    "criterion": "age group",
                    "requirements": [
                        {
                            "requirement_type": "expected age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic prostate cancer",
                    "criterion": "prostate cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled to receive LHRH analogues",
                    "criterion": "treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "planned treatment",
                            "expected_value": "LHRH analogues"
                        }
                    ]
                },
                {
                    "exact_snippets": "completed an IPSS questionnaire",
                    "criterion": "IPSS questionnaire completion",
                    "requirements": [
                        {
                            "requirement_type": "completion status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "This last visit has to be done 6 months before the baseline visit",
                    "criterion": "timing of last visit",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients having provided written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patients having provided written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients mentally fit for completing a self-administered questionnaire",
            "criterions": [
                {
                    "exact_snippets": "mentally fit for completing a self-administered questionnaire",
                    "criterion": "mental fitness",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "completing a self-administered questionnaire"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Any surgical or radiotherapy treatment performed at prostate level before the entry of the study",
            "criterions": [
                {
                    "exact_snippets": "surgical ... treatment performed at prostate level",
                    "criterion": "surgical treatment at prostate level",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiotherapy treatment performed at prostate level",
                    "criterion": "radiotherapy treatment at prostate level",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient with castrate levels of testosterone ( < 50 ng/dL) at his first IPSS questionnaire",
            "criterions": [
                {
                    "exact_snippets": "castrate levels of testosterone ( < 50 ng/dL)",
                    "criterion": "testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are also participating in any other clinical study within the last 2 months before study entry",
            "criterions": [
                {
                    "exact_snippets": "Patients who are also participating in any other clinical study within the last 2 months before study entry",
                    "criterion": "participation in other clinical study",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of less than 12 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of less than 12 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}