{
    "info": {
        "nct_id": "NCT05346848",
        "official_title": "A Randomized Non-comparative Phase II Multicentric Trial on Short Term Darolutamide (ODM-201) Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer",
        "inclusion_criteria": "1. Age ≥ 18,\n2. Histological diagnosis of prostate malignancy cancer\n3. Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),\n4. Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.\n\n   One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:\n   * Gleason = 7 (4+3)\n   * ≥ 50% of thecore of biopsies need to be positive for adenocarcinoma\n\n   If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:\n   * PSA value between 10-20 ng/ml\n   * Gleason 7 (3+4) or 6\n   * T2b (clinical or radiological) Note: patients with iT3a can be included only if gleason score is 6 and PSA less than 20 .\n5. Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration\n6. Patients must have a life expectancy of at least 5 years,\n7. Performance status ECOG ≤ 2,\n8. Patients without contra-indications to EBRT as per physician judgement,\n9. Patients with adequate organ function defined by all the following laboratory values\n10. Available archived paraffin-embedded tumor sample for research purpose,\n11. Patients with a social security in compliance with the french law,\n12. Voluntary signed and dated written informed consent prior to any study specific procedure,\n13. Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,\n2. Patients with Gleason score ≥8,\n3. Patients with PSA >20 ng/ml,\n4. Presence of loco-regional or distant metastasis,\n5. Contra-indications to MRI and to contrast-enhanced CT-scan,\n6. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.\n7. Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,\n8. Patients with previous orchiectomy\n9. Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,\n10. Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,\n11. Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,\n12. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),\n13. History of cerebrovascular accident (within the last 6 months)\n14. Impaired cardiac function as defined in the Protocol\n15. Uncontrolled hypertension\n16. Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug,\n17. Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,\n18. Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues\n19. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome\n20. Men who are not using an effective method of contraception as previously described\n21. Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,\n22. History of non-compliance to medical regimens or inability to grant consent,\n23. Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,\n24. Individuals under judicial protection or deprived of liberty.\n25. Inability to swallow or to give subcutaneous or intramuscular injections.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Age ≥ 18,",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histological diagnosis of prostate malignancy cancer",
            "criterions": [
                {
                    "exact_snippets": "Histological diagnosis of prostate malignancy cancer",
                    "criterion": "prostate malignancy cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis method",
                            "expected_value": "histological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Cancer without loco-regional or distant metastasis (tumor assessment must comprise at least Pelvic MRI AND thoraco-abdomino-pelvic contrast-enhanced CT-Scan AND Bone Scintigraphy. (Note that additional assessment by PET-Scan is allowed as per investigator judgement),",
            "criterions": [
                {
                    "exact_snippets": "Cancer without loco-regional or distant metastasis",
                    "criterion": "cancer metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor assessment must comprise at least Pelvic MRI",
                    "criterion": "tumor assessment",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "Pelvic MRI"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor assessment must comprise at least ... thoraco-abdomino-pelvic contrast-enhanced CT-Scan",
                    "criterion": "tumor assessment",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "thoraco-abdomino-pelvic contrast-enhanced CT-Scan"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumor assessment must comprise at least ... Bone Scintigraphy",
                    "criterion": "tumor assessment",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "Bone Scintigraphy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "additional assessment by PET-Scan is allowed as per investigator judgement",
                    "criterion": "tumor assessment",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "PET-Scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Unfavorable intermediate risk prostate cancer diagnosis defined by the NCCN Guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Unfavorable intermediate risk prostate cancer diagnosis",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "risk category",
                            "expected_value": "unfavorable intermediate"
                        }
                    ]
                },
                {
                    "exact_snippets": "defined by the NCCN Guidelines",
                    "criterion": "NCCN Guidelines definition",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "One of the following criteria is sufficient to define an unfavorable intermediate risk prostate cancer:",
            "criterions": [
                {
                    "exact_snippets": "unfavorable intermediate risk prostate cancer",
                    "criterion": "prostate cancer risk",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "unfavorable intermediate"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason = 7 (4+3)",
            "criterions": [
                {
                    "exact_snippets": "Gleason = 7 (4+3)",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "If these criteria are not being identified, two or three of the following criteria are necessary to define unfavorable intermediate risk prostate cancer:",
            "criterions": [
                {
                    "exact_snippets": "unfavorable intermediate risk prostate cancer",
                    "criterion": "unfavorable intermediate risk prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "two or three of the following criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA value between 10-20 ng/ml",
            "criterions": [
                {
                    "exact_snippets": "PSA value between 10-20 ng/ml",
                    "criterion": "PSA value",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "ng/ml"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 20,
                                        "unit": "ng/ml"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason 7 (3+4) or 6",
            "criterions": [
                {
                    "exact_snippets": "Gleason 7 (3+4) or 6",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "7 (3+4)",
                                "6"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* T2b (clinical or radiological) Note: patients with iT3a can be included only if gleason score is 6 and PSA less than 20 .",
            "criterions": [
                {
                    "exact_snippets": "T2b (clinical or radiological)",
                    "criterion": "T2b stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "iT3a ... gleason score is 6",
                    "criterion": "iT3a stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "gleason score",
                            "expected_value": {
                                "operator": "=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "iT3a ... PSA less than 20",
                    "criterion": "iT3a stage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "PSA level",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients newly diagnosed with an unfavorable intermediate risk prostate cancer according to the protocol criteria or previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer progressing to eligible risk disease according to the protocol criteria within 30 days before registration",
            "criterions": [
                {
                    "exact_snippets": "newly diagnosed with an unfavorable intermediate risk prostate cancer",
                    "criterion": "unfavorable intermediate risk prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "previously diagnosed with low risk (Gleason score < 6, clinical stage < T2a, and PSA< 10) prostate cancer",
                    "criterion": "low risk prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "previously diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score < 6",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical stage < T2a",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "T"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA< 10",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "progressing to eligible risk disease according to the protocol criteria within 30 days before registration",
                    "criterion": "progression to eligible risk disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 30 days before registration"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients must have a life expectancy of at least 5 years,",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 5 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Performance status ECOG ≤ 2,",
            "criterions": [
                {
                    "exact_snippets": "Performance status ECOG ≤ 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients without contra-indications to EBRT as per physician judgement,",
            "criterions": [
                {
                    "exact_snippets": "contra-indications to EBRT",
                    "criterion": "contra-indications to EBRT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients with adequate organ function defined by all the following laboratory values",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Available archived paraffin-embedded tumor sample for research purpose,",
            "criterions": [
                {
                    "exact_snippets": "Available archived paraffin-embedded tumor sample",
                    "criterion": "archived paraffin-embedded tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with a social security in compliance with the french law,",
            "criterions": [
                {
                    "exact_snippets": "social security in compliance with the french law",
                    "criterion": "social security",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": "french law"
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Voluntary signed and dated written informed consent prior to any study specific procedure,",
            "criterions": [
                {
                    "exact_snippets": "Voluntary signed and dated written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Men must agree to use an effective method of contraception throughout the treatment period and for one week after discontinuation of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Men must agree to use an effective method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "throughout the treatment period and for one week after discontinuation of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "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. Stage T3b-T4 prostate cancer by clinical examination or radiologic evaluation,",
            "criterions": [
                {
                    "exact_snippets": "Stage T3b-T4 prostate cancer",
                    "criterion": "prostate cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "T"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical examination",
                    "criterion": "clinical examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiologic evaluation",
                    "criterion": "radiologic evaluation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients with Gleason score ≥8,",
            "criterions": [
                {
                    "exact_snippets": "Gleason score ≥8",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients with PSA >20 ng/ml,",
            "criterions": [
                {
                    "exact_snippets": "PSA >20 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Presence of loco-regional or distant metastasis,",
            "criterions": [
                {
                    "exact_snippets": "Presence of loco-regional or distant metastasis",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "loco-regional",
                                "distant"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Contra-indications to MRI and to contrast-enhanced CT-scan,",
            "criterions": [
                {
                    "exact_snippets": "Contra-indications to MRI",
                    "criterion": "MRI",
                    "requirements": [
                        {
                            "requirement_type": "contra-indications",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Contra-indications to ... contrast-enhanced CT-scan",
                    "criterion": "contrast-enhanced CT-scan",
                    "requirements": [
                        {
                            "requirement_type": "contra-indications",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone less than 50 ng/dL or below the normal range for the institution.",
            "criterions": [
                {
                    "exact_snippets": "Hypogonadism or severe androgen deficiency",
                    "criterion": "hypogonadism or severe androgen deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "screening serum testosterone less than 50 ng/dL",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "screening serum testosterone ... below the normal range for the institution",
                    "criterion": "serum testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "below the normal range for the institution"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Previous prostate cancer treated by androgen deprivation, chemotherapy, surgery, or radiotherapy,",
            "criterions": [
                {
                    "exact_snippets": "Previous prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by androgen deprivation",
                    "criterion": "androgen deprivation treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by ... chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by ... surgery",
                    "criterion": "surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated by ... radiotherapy",
                    "criterion": "radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with previous orchiectomy",
            "criterions": [
                {
                    "exact_snippets": "Patients with previous orchiectomy",
                    "criterion": "previous orchiectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens, anti-androgens, estrogens, or progestational agents,",
            "criterions": [
                {
                    "exact_snippets": "Patients actively receiving or having received within 6 months prior enrollment any concurrent androgens",
                    "criterion": "androgens",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients actively receiving or having received within 6 months prior enrollment any concurrent ... anti-androgens",
                    "criterion": "anti-androgens",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients actively receiving or having received within 6 months prior enrollment any concurrent ... estrogens",
                    "criterion": "estrogens",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients actively receiving or having received within 6 months prior enrollment any concurrent ... progestational agents",
                    "criterion": "progestational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patients having received ketoconazole, finasteride or dutasteride within 30 days of inclusion,",
            "criterions": [
                {
                    "exact_snippets": "Patients having received ketoconazole ... within 30 days of inclusion",
                    "criterion": "ketoconazole",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients having received ... finasteride ... within 30 days of inclusion",
                    "criterion": "finasteride",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients having received ... dutasteride within 30 days of inclusion",
                    "criterion": "dutasteride",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Previous and current malignancies other than prostate cancer within the last 5 years with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, acute lymphoblastic leukemia, non-muscle invasive bladder cancer,",
            "criterions": [
                {
                    "exact_snippets": "Previous and current malignancies other than prostate cancer within the last 5 years",
                    "criterion": "malignancies",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than prostate cancer"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last 5 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of adequately treated basal cell or squamous cell carcinoma of the skin",
                    "criterion": "basal cell or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of ... acute lymphoblastic leukemia",
                    "criterion": "acute lymphoblastic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of ... non-muscle invasive bladder cancer",
                    "criterion": "non-muscle invasive bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection),",
            "criterions": [
                {
                    "exact_snippets": "Severe or uncontrolled medical conditions ... uncontrolled diabetes",
                    "criterion": "diabetes",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe or uncontrolled medical conditions ... active or uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": [
                                "active",
                                "uncontrolled"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. History of cerebrovascular accident (within the last 6 months)",
            "criterions": [
                {
                    "exact_snippets": "History of cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the last 6 months",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Impaired cardiac function as defined in the Protocol",
            "criterions": [
                {
                    "exact_snippets": "Impaired cardiac function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "impairment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Uncontrolled hypertension",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug,",
            "criterions": [
                {
                    "exact_snippets": "Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of study drug",
                    "criterion": "gastrointestinal function or GI disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on drug absorption",
                            "expected_value": "may significantly alter"
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Major surgery within 4 weeks prior enrolment except pelvic lymph-nodes dissection,",
            "criterions": [
                {
                    "exact_snippets": "Major surgery within 4 weeks prior enrolment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except pelvic lymph-nodes dissection",
                    "criterion": "pelvic lymph-nodes dissection",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Known hypersensitivity to any involved study drug or of its formulation components, to natural gonadotrophin releasing hormone or its analogues",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to any involved study drug",
                    "criterion": "hypersensitivity to study drug",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... of its formulation components",
                    "criterion": "hypersensitivity to formulation components",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to natural gonadotrophin releasing hormone",
                    "criterion": "hypersensitivity to natural gonadotrophin releasing hormone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity ... to ... its analogues",
                    "criterion": "hypersensitivity to analogues of gonadotrophin releasing hormone",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome",
            "criterions": [
                {
                    "exact_snippets": "Galactose intolerance",
                    "criterion": "galactose intolerance",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "total lactase deficiency",
                    "criterion": "total lactase deficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "glucose-galactose malabsorption syndrome",
                    "criterion": "glucose-galactose malabsorption syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Men who are not using an effective method of contraception as previously described",
            "criterions": [
                {
                    "exact_snippets": "Men who are not using an effective method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "21. Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES,",
            "criterions": [
                {
                    "exact_snippets": "Use of herbal or alternative remedies that may affect hormonal status such as Prostasol or PC-SPES",
                    "criterion": "use of herbal or alternative remedies",
                    "requirements": [
                        {
                            "requirement_type": "affect on hormonal status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "22. History of non-compliance to medical regimens or inability to grant consent,",
            "criterions": [
                {
                    "exact_snippets": "History of non-compliance to medical regimens",
                    "criterion": "non-compliance to medical regimens",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "inability to grant consent",
                    "criterion": "ability to grant consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "23. Patient unable to follow and comply with the study procedures because of any geographical, social or psychpsychological reasons,",
            "criterions": [
                {
                    "exact_snippets": "unable to follow and comply with the study procedures",
                    "criterion": "ability to comply with study procedures",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "geographical",
                    "criterion": "geographical reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "social",
                    "criterion": "social reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychpsychological",
                    "criterion": "psychological reasons",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "24. Individuals under judicial protection or deprived of liberty.",
            "criterions": [
                {
                    "exact_snippets": "Individuals under judicial protection",
                    "criterion": "judicial protection status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "under judicial protection"
                        }
                    ]
                },
                {
                    "exact_snippets": "deprived of liberty",
                    "criterion": "liberty status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "deprived of liberty"
                        }
                    ]
                }
            ]
        },
        {
            "line": "25. Inability to swallow or to give subcutaneous or intramuscular injections.",
            "criterions": [
                {
                    "exact_snippets": "Inability to swallow",
                    "criterion": "swallowing ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability ... to give subcutaneous or intramuscular injections",
                    "criterion": "ability to give subcutaneous or intramuscular injections",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* ≥ 50% of thecore of biopsies need to be positive for adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "≥ 50% of the core of biopsies need to be positive for adenocarcinoma",
                    "criterion": "biopsy core positivity for adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}