{
    "info": {
        "nct_id": "NCT03328091",
        "official_title": "Genetic Counseling Processes and Outcomes Among Males With Prostate Cancer (ProGen)",
        "inclusion_criteria": "* Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)\n* Localized prostate cancer with Gleason score ≥8\n* Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months\n* Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart\n* Prostate cancer diagnosed at age ≤ 55 years\n* Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.\n* Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.\n* Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.\n* Active hematologic malignancy (e.g. CLL)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)",
            "criterions": [
                {
                    "exact_snippets": "Metastatic prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone-sensitive",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "hormone sensitivity",
                            "expected_value": "sensitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "de novo",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "disease status",
                            "expected_value": "de novo"
                        }
                    ]
                },
                {
                    "exact_snippets": "castration resistant",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "castration resistance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Localized prostate cancer with Gleason score ≥8",
            "criterions": [
                {
                    "exact_snippets": "Localized prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score ≥8",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rising PSA after prostatectomy or radiation with PSA doubling time ≤ 6 months",
            "criterions": [
                {
                    "exact_snippets": "Rising PSA after prostatectomy or radiation",
                    "criterion": "PSA status",
                    "requirements": [
                        {
                            "requirement_type": "trend",
                            "expected_value": "rising"
                        },
                        {
                            "requirement_type": "post-treatment",
                            "expected_value": [
                                "prostatectomy",
                                "radiation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA doubling time ≤ 6 months",
                    "criterion": "PSA doubling time",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent PSA after prostatectomy for PSA ≥ 0.2 ng/mL observed in testing at least 1 week apart",
            "criterions": [
                {
                    "exact_snippets": "Persistent PSA after prostatectomy",
                    "criterion": "persistent PSA after prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA ≥ 0.2 ng/mL",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.2,
                                "unit": "ng/mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "observed in testing at least 1 week apart",
                    "criterion": "PSA testing interval",
                    "requirements": [
                        {
                            "requirement_type": "interval",
                            "expected_value": "at least 1 week apart"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer diagnosed at age ≤ 55 years",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer diagnosed",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "age at diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 55,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer and a personal history of prior malignancy that does not include non-melanoma skin cancer or superficial bladder cancer.",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "personal history of prior malignancy",
                    "criterion": "personal history of prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "superficial bladder cancer"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate cancer diagnosis (any grade/stage) or prostate biopsy with high grade PIN or small acinar proliferation and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age ≤ 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives)",
            "criterions": [
                {
                    "exact_snippets": "Prostate cancer diagnosis (any grade/stage)",
                    "criterion": "prostate cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate biopsy with high grade PIN",
                    "criterion": "high grade PIN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prostate biopsy with ... small acinar proliferation",
                    "criterion": "small acinar proliferation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "family history potentially indicating a germline mutation",
                    "criterion": "family history of germline mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer diagnosed at age ≤ 50",
                    "criterion": "family history of breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "age of diagnosis",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second-degree relatives",
                    "criterion": "family history of specific cancers",
                    "requirements": [
                        {
                            "requirement_type": "cancer types",
                            "expected_value": [
                                "ovarian",
                                "pancreatic",
                                "uterine",
                                "colorectal",
                                "prostate",
                                "sarcoma"
                            ]
                        },
                        {
                            "requirement_type": "relationship",
                            "expected_value": [
                                "first-degree relatives",
                                "second-degree relatives"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Localized prostate cancer previously treated and in remission for > 2 years unless family history potentially indicates a germline mutation.",
            "criterions": [
                {
                    "exact_snippets": "Localized prostate cancer previously treated",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "previously treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Localized prostate cancer ... in remission for > 2 years",
                    "criterion": "localized prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "remission duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "family history potentially indicates a germline mutation",
                    "criterion": "family history",
                    "requirements": [
                        {
                            "requirement_type": "potential germline mutation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hematologic malignancy (e.g. CLL)",
            "criterions": [
                {
                    "exact_snippets": "Active hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Previous cancer genetic testing or counseling, or prior germline multigene panel testing. Previous tumor sequencing is acceptable if no genetic counseling took place.",
            "criterions": [
                {
                    "exact_snippets": "Previous cancer genetic testing",
                    "criterion": "previous cancer genetic testing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "previous cancer genetic ... prior germline multigene panel testing",
                    "criterion": "prior germline multigene panel testing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous tumor sequencing ... if no genetic counseling took place",
                    "criterion": "previous tumor sequencing without genetic counseling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}