{
    "info": {
        "nct_id": "NCT05917860",
        "official_title": "Effect of Neoadjuvant Degarelix on MRI-guided Transurethral Ultrasound Ablation (TULSA) in Patients with Intermediate-risk Prostate Cancer: a Pilot Study",
        "inclusion_criteria": "* Male age ≥ 40 years and candidate for radical prostate cancer treatment\n* Estimated life expectancy > 8 years\n* At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging-Reporting and Data System v2 (PI-RADS v2.1) ≥ 3\n* Biopsy-confirmed, intermediate-risk localized prostate cancer:\n* Clinical or radiological tumor stage ≤ T2c, N0, M0\n* ISUP GG 2 or 3\n* Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment\n* PSA ≤ 20 ng/ml\n* No prior definitive treatment of prostate cancer\n* Eligible for MRI\n* Eligible for general anesthesia (American Society of Anesthesiologists Class III or less)\n* Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued three months before and throughout the study period.\n* Informed consent: The patient must speak Finnish, English, or Swedish and must be able to understand the meaning of the study. The patient must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 40 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Prior prostate cancer treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen-receptor signaling inhibitors.\n* Relative or absolute contraindication to Degarelix\n* Severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months.\n* Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.)\n* Severe kidney failure as determined by estimated glomerular filtration rate (eGFR) less than 30 ml/min per 1.73 m2\n* Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumor\n* Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumor\n* Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET]) or histopathology\n* History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)\n* Hip replacement surgery or other metal in the pelvic area\n* Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug glucagon\n* Concomitant treatment with medications contraindicated to Glucagen used as antispasmolytic agent during TULSA treatment (e.g., Feochromocytoma)\n* Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist\n* Another primary malignancy unless disease-free survival is > 8 years",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male age ≥ 40 years and candidate for radical prostate cancer treatment",
            "criterions": [
                {
                    "exact_snippets": "Male",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "age ≥ 40 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "candidate for radical prostate cancer treatment",
                    "criterion": "treatment candidacy",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radical prostate cancer treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated life expectancy > 8 years",
            "criterions": [
                {
                    "exact_snippets": "Estimated life expectancy > 8 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least one MRI-visible and biopsy-concordant tumor defined as Prostate Imaging-Reporting and Data System v2 (PI-RADS v2.1) ≥ 3",
            "criterions": [
                {
                    "exact_snippets": "At least one MRI-visible and biopsy-concordant tumor",
                    "criterion": "MRI-visible and biopsy-concordant tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prostate Imaging-Reporting and Data System v2 (PI-RADS v2.1) ≥ 3",
                    "criterion": "PI-RADS v2.1 score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy-confirmed, intermediate-risk localized prostate cancer:",
            "criterions": [
                {
                    "exact_snippets": "Biopsy-confirmed",
                    "criterion": "biopsy confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate-risk",
                    "criterion": "risk level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "intermediate"
                        }
                    ]
                },
                {
                    "exact_snippets": "localized prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical or radiological tumor stage ≤ T2c, N0, M0",
            "criterions": [
                {
                    "exact_snippets": "Clinical or radiological tumor stage ≤ T2c",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "c"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "N0",
                    "criterion": "lymph node involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "M0",
                    "criterion": "distant metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ISUP GG 2 or 3",
            "criterions": [
                {
                    "exact_snippets": "ISUP GG 2 or 3",
                    "criterion": "ISUP GG",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "2",
                                "3"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment",
            "criterions": [
                {
                    "exact_snippets": "Biopsy obtained ≥ 6 weeks and ≤ 12 months before treatment",
                    "criterion": "biopsy timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 6,
                                        "unit": "weeks"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA ≤ 20 ng/ml",
            "criterions": [
                {
                    "exact_snippets": "PSA ≤ 20 ng/ml",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior definitive treatment of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "No prior definitive treatment of prostate cancer",
                    "criterion": "prior definitive treatment of prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for MRI",
            "criterions": [
                {
                    "exact_snippets": "Eligible for MRI",
                    "criterion": "MRI eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for general anesthesia (American Society of Anesthesiologists Class III or less)",
            "criterions": [
                {
                    "exact_snippets": "Eligible for general anesthesia",
                    "criterion": "general anesthesia eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "American Society of Anesthesiologists Class III or less",
                    "criterion": "American Society of Anesthesiologists classification",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "ASA Class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients taking 5-alpha reductase inhibitors (5-ARIs) are eligible if use is discontinued three months before and throughout the study period.",
            "criterions": [
                {
                    "exact_snippets": "Patients taking 5-alpha reductase inhibitors (5-ARIs)",
                    "criterion": "5-alpha reductase inhibitors (5-ARIs) use",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": "three months before and throughout the study period"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Informed consent: The patient must speak Finnish, English, or Swedish and must be able to understand the meaning of the study. The patient must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff.",
            "criterions": [
                {
                    "exact_snippets": "The patient must speak Finnish, English, or Swedish",
                    "criterion": "language proficiency",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "Finnish",
                                "English",
                                "Swedish"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must be able to understand the meaning of the study",
                    "criterion": "understanding of study",
                    "requirements": [
                        {
                            "requirement_type": "comprehension",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing and able to sign the appropriate Ethics Committee (EC) approved informed consent documents",
                    "criterion": "willingness and ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 40 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 40 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "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 prostate cancer treatment with chemotherapy or hormonal therapy, including chemical or surgical castration, antiandrogen therapy, or androgen-receptor signaling inhibitors.",
            "criterions": [
                {
                    "exact_snippets": "Prior prostate cancer treatment with chemotherapy",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior prostate cancer treatment with ... hormonal therapy",
                    "criterion": "prior hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior prostate cancer treatment with ... chemical ... castration",
                    "criterion": "prior chemical castration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior prostate cancer treatment with ... surgical castration",
                    "criterion": "prior surgical castration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior prostate cancer treatment with ... antiandrogen therapy",
                    "criterion": "prior antiandrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior prostate cancer treatment with ... androgen-receptor signaling inhibitors",
                    "criterion": "prior androgen-receptor signaling inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relative or absolute contraindication to Degarelix",
            "criterions": [
                {
                    "exact_snippets": "Relative or absolute contraindication to Degarelix",
                    "criterion": "contraindication to Degarelix",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "relative",
                                "absolute"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe, active cardiovascular comorbidity including unstable angina pectoris, congestive heart failure, deep vein thrombosis, pulmonary embolism, or myocardial infarction within the last six months.",
            "criterions": [
                {
                    "exact_snippets": "Severe, active cardiovascular comorbidity including unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe, active cardiovascular comorbidity including ... congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe, active cardiovascular comorbidity including ... deep vein thrombosis",
                    "criterion": "deep vein thrombosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe, active cardiovascular comorbidity including ... pulmonary embolism",
                    "criterion": "pulmonary embolism",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Severe, active cardiovascular comorbidity including ... myocardial infarction within the last six months",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the last six months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to undergo MRI due to claustrophobia or contraindications (cardiac pacemaker, intracranial clips, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Inability to undergo MRI due to claustrophobia",
                    "criterion": "MRI capability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contraindications (cardiac pacemaker, intracranial clips, etc.)",
                    "criterion": "MRI contraindications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe kidney failure as determined by estimated glomerular filtration rate (eGFR) less than 30 ml/min per 1.73 m2",
            "criterions": [
                {
                    "exact_snippets": "Severe kidney failure as determined by estimated glomerular filtration rate (eGFR) less than 30 ml/min per 1.73 m2",
                    "criterion": "estimated glomerular filtration rate (eGFR)",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min per 1.73 m2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate calcifications obstructing the planned ultrasound beam path in the line of sight of the MRI visible tumor",
            "criterions": [
                {
                    "exact_snippets": "Prostate calcifications obstructing the planned ultrasound beam path",
                    "criterion": "prostate calcifications",
                    "requirements": [
                        {
                            "requirement_type": "obstruction",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "MRI visible tumor",
                    "criterion": "tumor visibility on MRI",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumor",
            "criterions": [
                {
                    "exact_snippets": "Prostate cysts at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumor",
                    "criterion": "prostate cysts",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "at the prostate capsule within the planned ultrasound beam path in the line of sight of the MRI visible tumor"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET]) or histopathology",
            "criterions": [
                {
                    "exact_snippets": "Evidence of extraprostatic disease based on imaging (MRI, bone scintigraphy, single-photon emission tomography, computed tomography, prostate-specific membrane antigen-positron emission tomography [PSMA-PET])",
                    "criterion": "extraprostatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of extraprostatic disease ... histopathology",
                    "criterion": "extraprostatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of chronic inflammatory conditions (e.g., inflammatory bowel disease) affecting the rectum (also includes rectal fistula and anal/rectal stenosis)",
            "criterions": [
                {
                    "exact_snippets": "History of chronic inflammatory conditions (e.g., inflammatory bowel disease)",
                    "criterion": "chronic inflammatory conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "affecting the rectum",
                    "criterion": "rectum involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rectal fistula",
                    "criterion": "rectal fistula",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anal/rectal stenosis",
                    "criterion": "anal/rectal stenosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hip replacement surgery or other metal in the pelvic area",
            "criterions": [
                {
                    "exact_snippets": "Hip replacement surgery",
                    "criterion": "hip replacement surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metal in the pelvic area",
                    "criterion": "metal in the pelvic area",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergy or contraindication to gadolinium or gastro-intestinal anti-spasmodic drug glucagon",
            "criterions": [
                {
                    "exact_snippets": "Known allergy or contraindication to gadolinium",
                    "criterion": "gadolinium",
                    "requirements": [
                        {
                            "requirement_type": "allergy or contraindication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known allergy or contraindication to ... gastro-intestinal anti-spasmodic drug glucagon",
                    "criterion": "gastro-intestinal anti-spasmodic drug glucagon",
                    "requirements": [
                        {
                            "requirement_type": "allergy or contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concomitant treatment with medications contraindicated to Glucagen used as antispasmolytic agent during TULSA treatment (e.g., Feochromocytoma)",
            "criterions": [
                {
                    "exact_snippets": "Concomitant treatment with medications contraindicated to Glucagen",
                    "criterion": "concomitant treatment with contraindicated medications",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": "Glucagen"
                        }
                    ]
                },
                {
                    "exact_snippets": "used as antispasmolytic agent during TULSA treatment",
                    "criterion": "use of Glucagen",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "antispasmolytic agent during TULSA treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Feochromocytoma",
                    "criterion": "Feochromocytoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any other conditions that might compromise patient safety, based on the clinical judgment of the responsible urologist",
            "criterions": [
                {
                    "exact_snippets": "Any other conditions that might compromise patient safety",
                    "criterion": "conditions compromising patient safety",
                    "requirements": [
                        {
                            "requirement_type": "clinical judgment",
                            "expected_value": "responsible urologist"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Another primary malignancy unless disease-free survival is > 8 years",
            "criterions": [
                {
                    "exact_snippets": "Another primary malignancy unless disease-free survival is > 8 years",
                    "criterion": "primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease-free survival is > 8 years",
                    "criterion": "disease-free survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 8,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}