{
    "info": {
        "nct_id": "NCT01098331",
        "official_title": "Surgery and Brachytherapy: A Randomized Evaluation. Randomized Controlled Trial of Brachytherapy Versus Radical Prostatectomy in Good Risk Prostate Cancer: A Feasibility Study",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 120 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS\n\nMeeting 1 of the following criteria:\n\n* Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA < 15 ng/mL\n* Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc\n\nPATIENT CHARACTERISTICS:\n\n* WHO performance status 0-1\n* Life expectancy > 10 years (Decision-Aid Randomization)\n* Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial\n* No unacceptable risk for radical prostatectomy or prostate brachytherapy\n* INR < 1.5\n* No severe lower urinary tract symptoms\n* No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second, and/or post micturition bladder volume > 100 mL)\n* No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial\n* No other active malignancy likely to interfere with subsequent protocol treatment and follow-up\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior pelvic radiotherapy\n* No prior abdominoperineal (AP) rectal excision\n* No prior standard transurethral resection of prostate\n* No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)\n* At least 5 days since prior aspirin or clopidogrel\n* No concurrent warfarin"
    },
    "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 120 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 120 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 120,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS",
            "criterions": [
                {
                    "exact_snippets": "DISEASE CHARACTERISTICS",
                    "criterion": "disease characteristics",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Meeting 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "Meeting 1 of the following criteria",
                    "criterion": "criteria count",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer or suspected prostate cancer confined to the prostate (Decision-Aid Randomization) Clinical stage T1/T2, Due for prostate biopsy or prostate biopsy performed in the last 6 weeks, PSA < 15 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer or suspected prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confined to the prostate",
                    "criterion": "cancer confinement",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "prostate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage T1/T2",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Due for prostate biopsy or prostate biopsy performed in the last 6 weeks",
                    "criterion": "prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "due or performed in the last 6 weeks"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA < 15 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 15,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically confirmed prostate cancer (Treatment Randomization): Clinical stage T1/T2, Re-biopsy after a period of active surveillance is at the discretion of the treating investigator, Must meet 1 of the following risk criteria (PSA test < 3 months prior to treatment intervention), Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5) with a PSA of < 10 ng/mL, intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5) with a PSA > 10 ng/mL but ≤ 15 ng/mL, Transrectal ultrasound prostate volume ≤ 50 cc",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stage T1/T2",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "T1",
                                "T2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Re-biopsy after a period of active surveillance is at the discretion of the treating investigator",
                    "criterion": "re-biopsy",
                    "requirements": [
                        {
                            "requirement_type": "discretion",
                            "expected_value": "treating investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA test < 3 months prior to treatment intervention",
                    "criterion": "PSA test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Low risk: Gleason score ≤ 6 (no tertiary grade 4 or 5)",
                    "criterion": "Gleason score for low risk",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "tertiary grade",
                            "expected_value": [
                                "not 4",
                                "not 5"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Low risk: ... with a PSA of < 10 ng/mL",
                    "criterion": "PSA level for low risk",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate-risk: Gleason score 3 + 4 (no tertiary grade 5)",
                    "criterion": "Gleason score for intermediate risk",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": "3 + 4"
                        },
                        {
                            "requirement_type": "tertiary grade",
                            "expected_value": "not 5"
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate-risk: ... with a PSA > 10 ng/mL but ≤ 15 ng/mL",
                    "criterion": "PSA level for intermediate risk",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 10,
                                        "unit": "ng/mL"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "ng/mL"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Transrectal ultrasound prostate volume ≤ 50 cc",
                    "criterion": "prostate volume",
                    "requirements": [
                        {
                            "requirement_type": "volume",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "cc"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* WHO performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "WHO performance status 0-1",
                    "criterion": "WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy > 10 years (Decision-Aid Randomization)",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy > 10 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Satisfactory results from biochemical and hematological profiles that, in the opinion of the investigator, does not preclude patient from the trial",
            "criterions": [
                {
                    "exact_snippets": "Satisfactory results from biochemical ... profiles",
                    "criterion": "biochemical profile",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Satisfactory results from ... hematological profiles",
                    "criterion": "hematological profile",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No unacceptable risk for radical prostatectomy or prostate brachytherapy",
            "criterions": [
                {
                    "exact_snippets": "unacceptable risk for radical prostatectomy",
                    "criterion": "risk for radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acceptable"
                        }
                    ]
                },
                {
                    "exact_snippets": "unacceptable risk for ... prostate brachytherapy",
                    "criterion": "risk for prostate brachytherapy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "acceptable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* INR < 1.5",
            "criterions": [
                {
                    "exact_snippets": "INR < 1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe lower urinary tract symptoms",
            "criterions": [
                {
                    "exact_snippets": "No severe lower urinary tract symptoms",
                    "criterion": "lower urinary tract symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second, and/or post micturition bladder volume > 100 mL)",
            "criterions": [
                {
                    "exact_snippets": "No significant obstructive urinary symptoms (i.e., peak urine flow rate < 10 mL per second",
                    "criterion": "peak urine flow rate",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "mL per second"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant obstructive urinary symptoms ... post micturition bladder volume > 100 mL",
                    "criterion": "post micturition bladder volume",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 100,
                                "unit": "mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other clinical or medical condition that, in the opinion of the investigator, precludes patient from taking part in the trial",
            "criterions": [
                {
                    "exact_snippets": "No other clinical or medical condition ... precludes patient from taking part in the trial",
                    "criterion": "clinical or medical condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other active malignancy likely to interfere with subsequent protocol treatment and follow-up",
            "criterions": [
                {
                    "exact_snippets": "No other active malignancy",
                    "criterion": "active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY:",
            "criterions": [
                {
                    "exact_snippets": "PRIOR CONCURRENT THERAPY",
                    "criterion": "prior concurrent therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior pelvic radiotherapy",
            "criterions": [
                {
                    "exact_snippets": "No prior pelvic radiotherapy",
                    "criterion": "pelvic radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior abdominoperineal (AP) rectal excision",
            "criterions": [
                {
                    "exact_snippets": "No prior abdominoperineal (AP) rectal excision",
                    "criterion": "abdominoperineal (AP) rectal excision",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior standard transurethral resection of prostate",
            "criterions": [
                {
                    "exact_snippets": "No prior standard transurethral resection of prostate",
                    "criterion": "prior standard transurethral resection of prostate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior or concurrent neoadjuvant or adjuvant hormonal treatment, (e.g., LHRH agonists, or anti-androgens or estrogens)",
            "criterions": [
                {
                    "exact_snippets": "No prior or concurrent neoadjuvant or adjuvant hormonal treatment",
                    "criterion": "hormonal treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "LHRH agonists",
                    "criterion": "LHRH agonists",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-androgens",
                    "criterion": "anti-androgens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "estrogens",
                    "criterion": "estrogens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 5 days since prior aspirin or clopidogrel",
            "criterions": [
                {
                    "exact_snippets": "At least 5 days since prior aspirin",
                    "criterion": "aspirin usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 5 days since prior ... clopidogrel",
                    "criterion": "clopidogrel usage",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No concurrent warfarin",
            "criterions": [
                {
                    "exact_snippets": "No concurrent warfarin",
                    "criterion": "warfarin use",
                    "requirements": [
                        {
                            "requirement_type": "concurrent use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "PATIENT CHARACTERISTICS:",
            "criterions": []
        }
    ]
}