{
    "info": {
        "nct_id": "NCT01230866",
        "official_title": "A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate",
        "inclusion_criteria": "* Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.\n* History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.\n* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.\n* PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.\n* Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.\n* No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.\n* Patients must be at least 18 years old.\n* ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.\n* IPSS score <= 16.\n* Patients must give IRB approved, study specific, informed consent.\n* Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.\n* Patients must be able to start treatment within 56 days of randomization.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.\n* Previous pelvic radiation for prostate cancer.\n* Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.\n* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.\n* Prior systemic chemotherapy for prostate cancer.\n* History of proximal urethral stricture requiring dilatation.\n* Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).\n* Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.\n* Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically confirmed prostate adenocarcinoma within 365 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Histologically confirmed prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 365 days prior to randomization",
                    "criterion": "diagnosis timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 365,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History/physical examination with digital rectal examination of the prostate and baseline toxicity assessment within 90 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "History/physical examination",
                    "criterion": "history and physical examination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "digital rectal examination of the prostate",
                    "criterion": "digital rectal examination of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "baseline toxicity assessment",
                    "criterion": "baseline toxicity assessment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 90 days prior to randomization",
                    "criterion": "timeframe for assessments",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly recommended.",
            "criterions": [
                {
                    "exact_snippets": "Histological evaluation of prostate biopsy",
                    "criterion": "prostate biopsy",
                    "requirements": [
                        {
                            "requirement_type": "evaluation",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "assignment of a Gleason score to the biopsy material",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "assignment",
                            "expected_value": "to biopsy material"
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score must be in the range of 2-6",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "> 6 cores are strongly recommended",
                    "criterion": "biopsy cores",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "cores"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to biopsy or at least 21 days after prostate biopsy.",
            "criterions": [
                {
                    "exact_snippets": "PSA values < 10 ng/ml",
                    "criterion": "PSA values",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 90 days prior to randomization",
                    "criterion": "PSA test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 90 days prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "Either done prior to biopsy or at least 21 days after prostate biopsy",
                    "criterion": "PSA test timing relative to biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "prior to biopsy",
                                "at least 21 days after prostate biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by treating investigator.",
            "criterions": [
                {
                    "exact_snippets": "Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.)",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": [
                                "T1a",
                                "T2a"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.)",
                    "criterion": "nodal involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.)",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "M0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Staging must be done by treating investigator",
                    "criterion": "staging responsibility",
                    "requirements": [
                        {
                            "requirement_type": "responsibility",
                            "expected_value": "treating investigator"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.",
            "criterions": [
                {
                    "exact_snippets": "pelvic lymph nodes > 1.5 cm in greatest dimension",
                    "criterion": "pelvic lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the enlarged lymph node is biopsied and negative",
                    "criterion": "enlarged lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "documented within 90 days prior to randomization",
                    "criterion": "documentation of ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 90 days prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* IPSS score <= 16.",
            "criterions": [
                {
                    "exact_snippets": "IPSS score <= 16",
                    "criterion": "IPSS score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 16,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must give IRB approved, study specific, informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients must give IRB approved, study specific, informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "IRB approved"
                        },
                        {
                            "requirement_type": "specificity",
                            "expected_value": "study specific"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must complete all mandatory tests listed in section 4.0 within the specified time frames.",
            "criterions": [
                {
                    "exact_snippets": "complete all mandatory tests",
                    "criterion": "mandatory tests",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the specified time frames",
                    "criterion": "time frames for tests",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": "specified time frames"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to start treatment within 56 days of randomization.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to start treatment within 56 days of randomization.",
                    "criterion": "treatment start time",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 56,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous prostate cancer surgery to include: prostatectomy, hyperthermia and cryosurgery.",
            "criterions": [
                {
                    "exact_snippets": "Previous prostate cancer surgery to include: prostatectomy",
                    "criterion": "previous prostate cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "prostatectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous prostate cancer surgery to include: ... hyperthermia",
                    "criterion": "previous prostate cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "hyperthermia"
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous prostate cancer surgery to include: ... cryosurgery",
                    "criterion": "previous prostate cancer surgery",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "cryosurgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous pelvic radiation for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Previous pelvic radiation for prostate cancer.",
                    "criterion": "pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous pelvic radiation for prostate cancer.",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Androgen deprivation therapy prior to radiation is allowed. However, it is not acceptable if continued during radiation or as adjuvant therapy.",
            "criterions": [
                {
                    "exact_snippets": "Androgen deprivation therapy prior to radiation is allowed",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "it is not acceptable if continued during radiation",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not during radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "it is not acceptable if continued ... as adjuvant therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "not as adjuvant therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis.",
            "criterions": [
                {
                    "exact_snippets": "Active rectal diverticulitis",
                    "criterion": "rectal diverticulitis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Crohn's disease affecting the rectum",
                    "criterion": "Crohn's disease",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "rectum"
                        }
                    ]
                },
                {
                    "exact_snippets": "ulcerative colitis",
                    "criterion": "ulcerative colitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior systemic chemotherapy for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Prior systemic chemotherapy for prostate cancer",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of proximal urethral stricture requiring dilatation.",
            "criterions": [
                {
                    "exact_snippets": "History of proximal urethral stricture",
                    "criterion": "proximal urethral stricture",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring dilatation",
                    "criterion": "dilatation",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless it can be stopped to manage treatment related toxicity, to have a biopsy if needed, or for marker placement).",
            "criterions": [
                {
                    "exact_snippets": "Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin, low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent.",
                    "criterion": "anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": [
                                "warfarin sodium",
                                "heparin",
                                "low-molecular weight heparin",
                                "Clopidogrel bisulfate",
                                "equivalent"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "current and continuing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any major medical, addictive or psychiatric illnesses which would affect the consent process, completion of treatment and/or interfere with follow-up. Consent by legal authorized representative is not permitted in this study.",
            "criterions": [
                {
                    "exact_snippets": "major medical, addictive or psychiatric illnesses",
                    "criterion": "medical, addictive or psychiatric illnesses",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "major"
                        }
                    ]
                },
                {
                    "exact_snippets": "Consent by legal authorized representative is not permitted",
                    "criterion": "consent by legal authorized representative",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of any other cancer within the past 5 years and < 50% probability of a 5 year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed).",
            "criterions": [
                {
                    "exact_snippets": "Evidence of any other cancer within the past 5 years",
                    "criterion": "other cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "< 50% probability of a 5 year survival",
                    "criterion": "5 year survival probability",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior or concurrent diagnosis of basal cell or non-invasive squamous cell cancer of the skin is allowed",
                    "criterion": "basal cell or non-invasive squamous cell cancer of the skin",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}