{
    "info": {
        "nct_id": "NCT05046782",
        "official_title": "Abbreviated Biparametric MRI (RSI + T2WI) for Prostate Cancer Detection: Correlation With Histopathology",
        "inclusion_criteria": "Primary Objective Cohort\n\n* Treatment naïve patients with histologically confirmed clinically significant prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm (42)) with a clinical indication for prostate mpMRI for pre-treatment tumor detection and staging\n* Patients with anticipated clinical follow-up who are anticipated to undergo surgery at MD Anderson.\n\nSecondary Objective Cohort\n\n* Treatment naïve patients with histologically confirmed intermediate risk prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm (42)) with a clinical indication for prostate mpMRI, who are to undergo target selection for fusion guided biopsy.\n* Patients who are anticipated to undergo fusion guided biopsy at MD Anderson.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who have already received androgen deprivation therapy or undergone prior surgery, radiotherapy or focal ablative therapies to the prostate\n* Patients whose weight exceeds 400 pounds\n* Patients allergic to gadolinium\n* Patients with pacemakers or other implantable devices or conditions that are a contraindication to MRI\n* Patients with conditions precluding MR imaging at 3T\n* Patients less than 18 years of age\n* Patients unable to provide informed consent\n* Patients unable to tolerate an endorectal coil\n* Patients who have undergone prostate biopsy less than 6 weeks prior to their MRI",
        "miscellaneous_criteria": "-"
    },
    "inclusion_lines": [
        {
            "line": "Primary Objective Cohort",
            "criterions": [
                {
                    "exact_snippets": "Primary Objective Cohort",
                    "criterion": "cohort",
                    "requirements": [
                        {
                            "requirement_type": "objective",
                            "expected_value": "primary"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment naïve patients with histologically confirmed clinically significant prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm (42)) with a clinical indication for prostate mpMRI for pre-treatment tumor detection and staging",
            "criterions": [
                {
                    "exact_snippets": "Treatment naïve patients",
                    "criterion": "treatment status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed clinically significant prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score > 3+4",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum cancer core length of > 4mm",
                    "criterion": "cancer core length",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical indication for prostate mpMRI for pre-treatment tumor detection and staging",
                    "criterion": "prostate mpMRI",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": "clinical indication for pre-treatment tumor detection and staging"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with anticipated clinical follow-up who are anticipated to undergo surgery at MD Anderson.",
            "criterions": [
                {
                    "exact_snippets": "anticipated clinical follow-up",
                    "criterion": "clinical follow-up",
                    "requirements": [
                        {
                            "requirement_type": "anticipated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anticipated to undergo surgery at MD Anderson",
                    "criterion": "surgery at MD Anderson",
                    "requirements": [
                        {
                            "requirement_type": "anticipated",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Secondary Objective Cohort",
            "criterions": [
                {
                    "exact_snippets": "Secondary Objective Cohort",
                    "criterion": "cohort type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "secondary objective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment naïve patients with histologically confirmed intermediate risk prostate cancer (defined as Gleason score > 3+4 and a maximum cancer core length of > 4mm (42)) with a clinical indication for prostate mpMRI, who are to undergo target selection for fusion guided biopsy.",
            "criterions": [
                {
                    "exact_snippets": "Treatment naïve patients",
                    "criterion": "treatment history",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "naïve"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed intermediate risk prostate cancer",
                    "criterion": "prostate cancer risk",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically"
                        },
                        {
                            "requirement_type": "risk level",
                            "expected_value": "intermediate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score > 3+4",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 3.4,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum cancer core length of > 4mm",
                    "criterion": "cancer core length",
                    "requirements": [
                        {
                            "requirement_type": "length",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical indication for prostate mpMRI",
                    "criterion": "clinical indication for prostate mpMRI",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergo target selection for fusion guided biopsy",
                    "criterion": "target selection for fusion guided biopsy",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "undergo"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are anticipated to undergo fusion guided biopsy at MD Anderson.",
            "criterions": [
                {
                    "exact_snippets": "anticipated to undergo fusion guided biopsy",
                    "criterion": "fusion guided biopsy",
                    "requirements": [
                        {
                            "requirement_type": "anticipated procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at MD Anderson",
                    "criterion": "location of procedure",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "MD Anderson"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Patients who have already received androgen deprivation therapy or undergone prior surgery, radiotherapy or focal ablative therapies to the prostate",
            "criterions": [
                {
                    "exact_snippets": "Patients who have already received androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone prior surgery ... to the prostate",
                    "criterion": "surgery to the prostate",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone prior ... radiotherapy ... to the prostate",
                    "criterion": "radiotherapy to the prostate",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone prior ... focal ablative therapies to the prostate",
                    "criterion": "focal ablative therapies to the prostate",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients whose weight exceeds 400 pounds",
            "criterions": [
                {
                    "exact_snippets": "weight exceeds 400 pounds",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 400,
                                "unit": "pounds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients allergic to gadolinium",
            "criterions": [
                {
                    "exact_snippets": "Patients allergic to gadolinium",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "substance",
                            "expected_value": "gadolinium"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with pacemakers or other implantable devices or conditions that are a contraindication to MRI",
            "criterions": [
                {
                    "exact_snippets": "Patients with pacemakers",
                    "criterion": "pacemaker",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other implantable devices",
                    "criterion": "implantable devices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "conditions that are a contraindication to MRI",
                    "criterion": "conditions contraindicated for MRI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with conditions precluding MR imaging at 3T",
            "criterions": [
                {
                    "exact_snippets": "conditions precluding MR imaging at 3T",
                    "criterion": "conditions precluding MR imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients less than 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "less than 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to provide informed consent",
            "criterions": [
                {
                    "exact_snippets": "unable to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients unable to tolerate an endorectal coil",
            "criterions": [
                {
                    "exact_snippets": "unable to tolerate an endorectal coil",
                    "criterion": "endorectal coil tolerance",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone prostate biopsy less than 6 weeks prior to their MRI",
            "criterions": [
                {
                    "exact_snippets": "undergone prostate biopsy less than 6 weeks prior to their MRI",
                    "criterion": "prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "-",
            "criterions": []
        }
    ]
}