{
    "info": {
        "nct_id": "NCT01087580",
        "official_title": "A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer",
        "inclusion_criteria": "* Participants must have a diagnosis of castrate resistant prostate cancer.\n* Participants must be 18 years old or older.\n* Biopsy of tissue from the prostate or enlarged lymph nodes may be required.\n* Patients must sign study specific informed consent prior to study entry.\n* Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participants cannot have prior chemotherapy for prostate cancer.\n* Participants cannot have prior radiation therapy to the pelvis.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have a diagnosis of castrate resistant prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of castrate resistant prostate cancer",
                    "criterion": "castrate resistant prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must be 18 years old or older.",
            "criterions": [
                {
                    "exact_snippets": "Participants must be 18 years old or older.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy of tissue from the prostate or enlarged lymph nodes may be required.",
            "criterions": [
                {
                    "exact_snippets": "Biopsy of tissue from the prostate ... may be required.",
                    "criterion": "biopsy of prostate tissue",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "may be required"
                        }
                    ]
                },
                {
                    "exact_snippets": "Biopsy of tissue from ... enlarged lymph nodes may be required.",
                    "criterion": "biopsy of enlarged lymph nodes",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": "may be required"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must sign study specific informed consent prior to study entry.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign study specific informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.",
            "criterions": [
                {
                    "exact_snippets": "Men of child-producing potential",
                    "criterion": "child-producing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must be willing to consent to use effective contraception",
                    "criterion": "willingness to use contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "while on treatment and for at least 3 months afterwards",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on treatment and for at least 3 months afterwards"
                        }
                    ]
                }
            ]
        },
        {
            "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": [
        {
            "line": "* Participants cannot have prior chemotherapy for prostate cancer.",
            "criterions": [
                {
                    "exact_snippets": "Participants cannot have prior chemotherapy for prostate cancer.",
                    "criterion": "prior chemotherapy for prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants cannot have prior radiation therapy to the pelvis.",
            "criterions": [
                {
                    "exact_snippets": "prior radiation therapy to the pelvis",
                    "criterion": "prior radiation therapy to the pelvis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}