{
    "info": {
        "nct_id": "NCT02940262",
        "official_title": "68Ga-PSMA PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy",
        "inclusion_criteria": "* Histopathological proven prostate adenocarcinoma\n* Rising PSA after definitive therapy with prostatectomy or radiation therapy.\n\n  * Post radical prostatectomy (RP)\n\n    * PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP\n  * Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition\n\n    * Nadir + greater than or equal to 2 ng/mL rise in PSA\n* Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/ World Health Organization [WHO] equivalent)\n* Ability to understand a written informed consent document, and the willingness to sign it\nHealthy volunteers allowed\nMust be MALE",
        "exclusion_criteria": "* Concomitant investigational therapy\n* Known inability to lie flat, remain still or tolerate a PET scan\n* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histopathological proven prostate adenocarcinoma",
            "criterions": [
                {
                    "exact_snippets": "Histopathological proven prostate adenocarcinoma",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological proven"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rising PSA after definitive therapy with prostatectomy or radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Rising PSA after definitive therapy with prostatectomy or radiation therapy.",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        }
                    ]
                },
                {
                    "exact_snippets": "definitive therapy with prostatectomy or radiation therapy",
                    "criterion": "definitive therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "prostatectomy",
                                "radiation therapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post radical prostatectomy (RP)",
            "criterions": [
                {
                    "exact_snippets": "Post radical prostatectomy (RP)",
                    "criterion": "radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* PSA equals to or greater than 0.2 ng/mL measured more than 6 weeks after RP",
            "criterions": [
                {
                    "exact_snippets": "PSA equals to or greater than 0.2 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "measured more than 6 weeks after RP",
                    "criterion": "time since RP",
                    "requirements": [
                        {
                            "requirement_type": "time since RP",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-radiation therapy - American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition",
            "criterions": [
                {
                    "exact_snippets": "Post-radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "American Society for Therapeutic Radiation and Oncology (ASTRO)-Phoenix consensus definition",
                    "criterion": "ASTRO-Phoenix consensus definition",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Nadir + greater than or equal to 2 ng/mL rise in PSA",
            "criterions": [
                {
                    "exact_snippets": "greater than or equal to 2 ng/mL rise in PSA",
                    "criterion": "PSA rise",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/ World Health Organization [WHO] equivalent)",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status of >= 50",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group [ECOG]/ World Health Organization [WHO] equivalent",
                    "criterion": "ECOG/WHO performance status",
                    "requirements": [
                        {
                            "requirement_type": "equivalent score",
                            "expected_value": "Karnofsky >= 50"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand a written informed consent document, and the willingness to sign it",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand a written informed consent document",
                    "criterion": "understanding of informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign it",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "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": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Concomitant investigational therapy",
            "criterions": [
                {
                    "exact_snippets": "Concomitant investigational therapy",
                    "criterion": "investigational therapy",
                    "requirements": [
                        {
                            "requirement_type": "concomitance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known inability to lie flat, remain still or tolerate a PET scan",
            "criterions": [
                {
                    "exact_snippets": "Known inability to lie flat",
                    "criterion": "ability to lie flat",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "remain still",
                    "criterion": "ability to remain still",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tolerate a PET scan",
                    "criterion": "ability to tolerate a PET scan",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer",
            "criterions": [
                {
                    "exact_snippets": "Patient undergoing active treatment for non-prostate malignancy",
                    "criterion": "active treatment for non-prostate malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized",
                    "criterion": "skin basal cell or cutaneous superficial squamous cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "superficial bladder cancer",
                    "criterion": "superficial bladder cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}