{
    "info": {
        "nct_id": "NCT04808427",
        "official_title": "Magnetic Resonance Image (MRI) Guided High Energy Ultrasound for Focal Prostate Cancer Ablation",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n\nSubjects must have prostate cancer amenable for ultrasound ablation defined as:\n\n* diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI;\n* Gleason Score <= 7;\n* MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group >= 2 prostate cancer must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). Systematic and targeted cores of Grade Group 1 prostate cancer outside of proposed ablation zone do not affect inclusion status, as these can be observed by conventional guideline management.\n* organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.\n* PSA < 20 ng/ml or PSA >20 with a PSA density <0.15.\n* Adults (>= 18 years of age)\n* Participants must have adequate organ and marrow function as defined below:\n\nPlatelets >= 50,000/mcL\n\nHemoglobin >= 8 g/dL\n\nMeasured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2\n\nGFR=glomerular filtration rate; ULN=upper limit of normal.\n\n*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n\n* Subjects must be able to understand and willing to sign a written informed consent document.\n* Subjects must be co-enrolled to NCI protocol 16-C-0010 \"Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue.\"\n\nEXCLUSION CRITERIA:\n\n* Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.\n* Target ablation volume greater than 100 ml.\n* Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.\n* Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)\n* Acute urinary tract infection\n* Lower urinary tract symptoms defined by an IPSS > 20\n* Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation (within time frame) that would limit compliance with study requirements."
    },
    "inclusion_lines": [
        {
            "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 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": [],
    "miscellaneous_lines": [
        {
            "line": "Subjects must have prostate cancer amenable for ultrasound ablation defined as:",
            "criterions": [
                {
                    "exact_snippets": "prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable for ultrasound ablation",
                    "criterion": "amenability for ultrasound ablation",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy and targeted biopsy of any MRI-visible or tracked lesions; pathological diagnosis must be confirmed by Laboratory of Pathology, NCI;",
            "criterions": [
                {
                    "exact_snippets": "diagnosed by transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy",
                    "criterion": "diagnosis method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "transrectal ultrasound-guided prostate biopsy via standard 12 core biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "targeted biopsy of any MRI-visible or tracked lesions",
                    "criterion": "lesion biopsy",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "targeted biopsy of any MRI-visible or tracked lesions"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathological diagnosis must be confirmed by Laboratory of Pathology, NCI",
                    "criterion": "pathological diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "Laboratory of Pathology, NCI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Gleason Score <= 7;",
            "criterions": [
                {
                    "exact_snippets": "Gleason Score <= 7",
                    "criterion": "Gleason Score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MRI-visible or MRI-tracked prostate cancer. This includes prostate cancer found on targeted biopsy of MRI-visible or MRI-tracked lesion. Histologically positive standard biopsy cores of Grade Group >= 2 prostate cancer must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s) and reviewed by NCI urologic pathologist. (Left / Right, Base, Mid-Gland, Apex). Systematic and targeted cores of Grade Group 1 prostate cancer outside of proposed ablation zone do not affect inclusion status, as these can be observed by conventional guideline management.",
            "criterions": [
                {
                    "exact_snippets": "MRI-visible or MRI-tracked prostate cancer",
                    "criterion": "prostate cancer visibility",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": [
                                "MRI-visible",
                                "MRI-tracked"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically positive standard biopsy cores of Grade Group >= 2 prostate cancer",
                    "criterion": "prostate cancer grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "Grade Group"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically positive standard biopsy cores ... must be from an area overlying or within 1cm of an MRI-visible or tracked lesion(s)",
                    "criterion": "biopsy core location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "overlying or within 1cm of an MRI-visible or tracked lesion(s)"
                        }
                    ]
                },
                {
                    "exact_snippets": "reviewed by NCI urologic pathologist",
                    "criterion": "pathologist review",
                    "requirements": [
                        {
                            "requirement_type": "review",
                            "expected_value": "NCI urologic pathologist"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* organ confined clinical T1c or clinical T2a prostate cancer that is visualized on MRI. Note: Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI are eligible.",
            "criterions": [
                {
                    "exact_snippets": "organ confined clinical T1c or clinical T2a prostate cancer",
                    "criterion": "prostate cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1c",
                                "T2a"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "visualized on MRI",
                    "criterion": "prostate cancer visibility on MRI",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants after prostate cancer treatment with local recurrence or residual tumor which is visible on MRI",
                    "criterion": "prostate cancer recurrence or residual tumor",
                    "requirements": [
                        {
                            "requirement_type": "visibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA < 20 ng/ml or PSA >20 with a PSA density <0.15.",
            "criterions": [
                {
                    "exact_snippets": "PSA < 20 ng/ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA >20 with a PSA density <0.15",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA density <0.15",
                    "criterion": "PSA density",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 0.15,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adults (>= 18 years of age)",
            "criterions": [
                {
                    "exact_snippets": "Adults (>= 18 years of age)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have adequate organ and marrow function as defined below:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ and marrow function",
                    "criterion": "organ and marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Platelets >= 50,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 50,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hemoglobin >= 8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin >= 8 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)* >= 30 mL/min/1.73 m^2",
            "criterions": [
                {
                    "exact_snippets": "Measured or calculated creatinine clearance (CrCl) ... >= 30 mL/min/1.73 m^2",
                    "criterion": "creatinine clearance (CrCl)",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "eGFR may also be used in place of CrCl ... >= 30 mL/min/1.73 m^2",
                    "criterion": "eGFR",
                    "requirements": [
                        {
                            "requirement_type": "measurement",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "GFR=glomerular filtration rate; ULN=upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "GFR=glomerular filtration rate",
                    "criterion": "GFR",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "glomerular filtration rate"
                        }
                    ]
                },
                {
                    "exact_snippets": "ULN=upper limit of normal",
                    "criterion": "ULN",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "upper limit of normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance (CrCl)",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": "per institutional standard"
                        }
                    ]
                },
                {
                    "exact_snippets": "eGFR",
                    "criterion": "estimated glomerular filtration rate",
                    "requirements": [
                        {
                            "requirement_type": "calculation",
                            "expected_value": "per institutional standard"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be able to understand and willing to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be able to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": "understand"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be co-enrolled to NCI protocol 16-C-0010 \"Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue.\"",
            "criterions": [
                {
                    "exact_snippets": "Subjects must be co-enrolled to NCI protocol 16-C-0010",
                    "criterion": "co-enrollment to NCI protocol 16-C-0010",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Targeted lesion ablation length from apex to base of >5 cm or lesion extending >3 cm from the urethra.",
            "criterions": [
                {
                    "exact_snippets": "Targeted lesion ablation length from apex to base of >5 cm",
                    "criterion": "targeted lesion ablation length",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lesion extending >3 cm from the urethra",
                    "criterion": "lesion extension from the urethra",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Target ablation volume greater than 100 ml.",
            "criterions": [
                {
                    "exact_snippets": "Target ablation volume greater than 100 ml.",
                    "criterion": "target ablation volume",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.",
            "criterions": [
                {
                    "exact_snippets": "Presence of calcifications that would impede ultrasound transmission between the urethra and ablative target.",
                    "criterion": "calcifications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "impact on ultrasound transmission",
                            "expected_value": "impede"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants are unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil; etc.)",
            "criterions": [
                {
                    "exact_snippets": "unable to tolerate MRI (foreign body, i.e., pacemaker or other implanted device;",
                    "criterion": "foreign body",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to tolerate MRI ... claustrophobia;",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to tolerate MRI ... inability to tolerate rectal coil;",
                    "criterion": "inability to tolerate rectal coil",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute urinary tract infection",
            "criterions": [
                {
                    "exact_snippets": "Acute urinary tract infection",
                    "criterion": "urinary tract infection",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acute"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lower urinary tract symptoms defined by an IPSS > 20",
            "criterions": [
                {
                    "exact_snippets": "Lower urinary tract symptoms defined by an IPSS > 20",
                    "criterion": "lower urinary tract symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "IPSS"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with uncontrolled coagulopathies (including liver dysfunction, or untreated hereditary coagulopathies which have a standard of care treatment) per surgeon discretion based on bleeding risk.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled coagulopathies",
                    "criterion": "coagulopathies",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "liver dysfunction",
                    "criterion": "liver dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated hereditary coagulopathies",
                    "criterion": "hereditary coagulopathies",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation (within time frame) that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situation (within time frame) that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situation",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "would not limit compliance"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}