{
    "info": {
        "nct_id": "NCT02151760",
        "official_title": "Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer",
        "inclusion_criteria": "* Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:\n\n  1. Greater than or equal to 18 years of age\n  2. Histological confirmation of prostate cancer\n  3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET\n  4. PSA ≥ 1.0 ng/mL\n  5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.\n  6. Platelet count > 50,000/mm3\n  7. Neutrophil count > 1,000/mm3\n  8. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.\n  9. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
        "exclusion_criteria": "* Patients will be excluded from enrollment if any of the following apply:\n\n  1. Karnovsky performance status of < 60\n  2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)\n  3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)\n  4. Administered a radioisotope within 5 physical half-lives prior to study enrollment\n  5. Serum creatinine > 3 times the upper limit of normal\n  6. Total bilirubin > 3 times the upper limit of normal\n  7. Liver Transaminases > 5times the upper limit of normal\n  8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration\n  9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).\n  10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Greater than or equal to 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Greater than or equal to 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Histological confirmation of prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmation of prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histological"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET",
            "criterions": [
                {
                    "exact_snippets": "Radiologic evidence of new or progressive metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "new or progressive"
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET",
                    "criterion": "imaging modality",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "ultrasound",
                                "bone scintigraphy",
                                "18F-Sodium Fluoride PET",
                                "18F-FDG PET"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. PSA ≥ 1.0 ng/mL",
            "criterions": [
                {
                    "exact_snippets": "PSA ≥ 1.0 ng/mL",
                    "criterion": "PSA",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.0,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.",
            "criterions": [
                {
                    "exact_snippets": "on androgen deprivation therapy",
                    "criterion": "androgen deprivation therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose stability",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Platelet count > 50,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count > 50,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 50000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Neutrophil count > 1,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Neutrophil count > 1,000/mm3",
                    "criterion": "neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.",
            "criterions": [
                {
                    "exact_snippets": "Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol",
                    "criterion": "compliance with the protocol",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "investigator's assessment"
                        }
                    ]
                },
                {
                    "exact_snippets": "be within geographical proximity to make the required study visits",
                    "criterion": "geographical proximity",
                    "requirements": [
                        {
                            "requirement_type": "proximity",
                            "expected_value": "within range for study visits"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.",
            "criterions": [
                {
                    "exact_snippets": "Patients or their legal representatives must have the ability to read, understand and provide written informed consent",
                    "criterion": "ability to provide informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 100 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 100 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Karnovsky performance status of < 60",
            "criterions": [
                {
                    "exact_snippets": "Karnovsky performance status of < 60",
                    "criterion": "Karnovsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)",
            "criterions": [
                {
                    "exact_snippets": "Inadequate venous access (two antecubital or equivalent venous access sites are required",
                    "criterion": "venous access",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "venous access sites"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)",
            "criterions": [
                {
                    "exact_snippets": "Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants)",
                    "criterion": "permanent prostate brachytherapy implant with Pd-103",
                    "requirements": [
                        {
                            "requirement_type": "time since implant",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient received a permanent prostate brachytherapy implant ... within the last ... 12 months (for I-125 implants)",
                    "criterion": "permanent prostate brachytherapy implant with I-125",
                    "requirements": [
                        {
                            "requirement_type": "time since implant",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Administered a radioisotope within 5 physical half-lives prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Administered a radioisotope within 5 physical half-lives prior to study enrollment",
                    "criterion": "radioisotope administration",
                    "requirements": [
                        {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "physical half-lives"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Serum creatinine > 3 times the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine > 3 times the upper limit of normal",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Total bilirubin > 3 times the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin > 3 times the upper limit of normal",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Liver Transaminases > 5times the upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "Liver Transaminases > 5times the upper limit of normal",
                    "criterion": "Liver Transaminases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).",
            "criterions": [
                {
                    "exact_snippets": "Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration",
                    "criterion": "prior radiation therapy or chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.",
            "criterions": [
                {
                    "exact_snippets": "Prior history of any other malignancy within 3 years",
                    "criterion": "prior history of malignancy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other than skin basal cell carcinoma",
                    "criterion": "exclusion of specific malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "skin basal cell carcinoma"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Patients will be excluded from enrollment if any of the following apply:",
            "criterions": []
        },
        {
            "line": "8. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration",
            "criterions": [
                {
                    "exact_snippets": "Patient has been treated with an investigational drug",
                    "criterion": "treatment with investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has been treated with an investigational biologic",
                    "criterion": "treatment with investigational biologic",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient has been treated with an investigational therapeutic device",
                    "criterion": "treatment with investigational therapeutic device",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}