{
    "info": {
        "nct_id": "NCT05582876",
        "official_title": "Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer",
        "inclusion_criteria": "Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned\n\n* Prostate adenocarcinoma confirmed by biopsy and histopathological examination\n* Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score> 7 or cT2c or PSA> 20 ng / ml) risk according to ISUP\n* Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance> 60 mL / min\n* Age ≥18 years\n* Signing informed consent to participate in the study\n* Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study\n\nGroup 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:\n\n* Prostate adenocarcinoma confirmed by biopsy and histopathological examination\n* After radical treatment\n* In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or\n* In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml\n* Age ≥18 years\n* Signing informed consent\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination\n* Claustrophobia\n* Patient size precluding PET / MR examination due to diameter gantry\n* Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)\n* Treatment for malignant neoplasm not associated with the prostate gland\n* Participating in another clinical trial\n* Lack of informed consent to participate in the study\n* Age <18 years",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned",
            "criterions": [
                {
                    "exact_snippets": "diagnosis or high probability of medium and high prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "probability",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "medium",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "International Society of Urological Pathology (ISUP) risk",
                    "criterion": "ISUP risk",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radical treatment is planned",
                    "criterion": "radical treatment",
                    "requirements": [
                        {
                            "requirement_type": "plan",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate adenocarcinoma confirmed by biopsy and histopathological examination",
            "criterions": [
                {
                    "exact_snippets": "Prostate adenocarcinoma confirmed by biopsy and histopathological examination",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "biopsy",
                                "histopathological examination"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score> 7 or cT2c or PSA> 20 ng / ml) risk according to ISUP",
            "criterions": [
                {
                    "exact_snippets": "Gleason score 7",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Gleason score> 7",
                    "criterion": "Gleason score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cT2b",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT2b"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT2c",
                    "criterion": "clinical stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "cT2c"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA 10-20 ng / ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "ng/ml"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 20,
                                        "unit": "ng/ml"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA> 20 ng / ml",
                    "criterion": "PSA level",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "ng/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance> 60 mL / min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine value ... creatinine less than or equal to 1.5 times the upper limit of normal",
                    "criterion": "creatinine value",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "times the upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance> 60 mL / min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "mL / min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signing informed consent to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Signing informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study",
            "criterions": [
                {
                    "exact_snippets": "Pelvic / prostate mpMR examination performed",
                    "criterion": "pelvic/prostate mpMR examination",
                    "requirements": [
                        {
                            "requirement_type": "performance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not earlier than 30 days before inclusion in the study",
                    "criterion": "timing of mpMR examination",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days before inclusion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:",
            "criterions": [
                {
                    "exact_snippets": "RGK after radical treatment",
                    "criterion": "RGK",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "after radical treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "biochemical recurrence according to EAU criteria",
                    "criterion": "biochemical recurrence",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "EAU"
                        }
                    ]
                },
                {
                    "exact_snippets": "scheduled for further treatment",
                    "criterion": "treatment schedule",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "scheduled for further treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "result of the imaging / molecular examination may affect change of therapeutic decision",
                    "criterion": "imaging / molecular examination result",
                    "requirements": [
                        {
                            "requirement_type": "impact",
                            "expected_value": "may affect change of therapeutic decision"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prostate adenocarcinoma confirmed by biopsy and histopathological examination",
            "criterions": [
                {
                    "exact_snippets": "Prostate adenocarcinoma confirmed by biopsy",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Prostate adenocarcinoma confirmed by ... histopathological examination",
                    "criterion": "prostate adenocarcinoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological examination"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* After radical treatment",
            "criterions": [
                {
                    "exact_snippets": "After radical treatment",
                    "criterion": "radical treatment",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or",
            "criterions": [
                {
                    "exact_snippets": "patients after radical prostatectomy",
                    "criterion": "radical prostatectomy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy",
                    "criterion": "PSA measurements",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "measurements"
                            }
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.2,
                                "unit": "ng/ml"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "not earlier than 6-13 weeks post-surgery"
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA≥0.1 with PSAdt (PSA doubling time) <3 months",
                    "criterion": "PSA level and doubling time",
                    "requirements": [
                        {
                            "requirement_type": "PSA level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 0.1,
                                "unit": "ng/ml"
                            }
                        },
                        {
                            "requirement_type": "PSA doubling time",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PSA on at least two consecutive studies in consecutive last 6 months before qualification",
                    "criterion": "PSA studies",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "studies"
                            }
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "consecutive last 6 months before qualification"
                        }
                    ]
                },
                {
                    "exact_snippets": "last determination within 6 weeks before qualification",
                    "criterion": "PSA determination timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 6 weeks before qualification"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml",
            "criterions": [
                {
                    "exact_snippets": "patients after radical radiotherapy",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "radical radiotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "biochemical recurrence defined as nadir PSA + 2 ng / ml",
                    "criterion": "biochemical recurrence",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "nadir PSA + 2 ng/ml"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥18 years",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signing informed consent",
            "criterions": [
                {
                    "exact_snippets": "Signing informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signing",
                            "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 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination",
            "criterions": [
                {
                    "exact_snippets": "Presence of metallic foreign bodies",
                    "criterion": "metallic foreign bodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of ... implants",
                    "criterion": "metallic implants",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of ... prostheses",
                    "criterion": "metallic prostheses",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of ... stimulators",
                    "criterion": "metallic stimulators",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Claustrophobia",
            "criterions": [
                {
                    "exact_snippets": "Claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient size precluding PET / MR examination due to diameter gantry",
            "criterions": [
                {
                    "exact_snippets": "Patient size precluding PET / MR examination due to diameter gantry",
                    "criterion": "patient size",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with PET / MR examination",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)",
            "criterions": [
                {
                    "exact_snippets": "Known contraindications for the use of radiopharmaceuticals",
                    "criterion": "contraindications for radiopharmaceuticals",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known contraindications for the use of ... substances auxiliary",
                    "criterion": "contraindications for auxiliary substances",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "renal failure",
                    "criterion": "renal failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "allergy to ingredients in the preparation",
                    "criterion": "allergy to ingredients in the preparation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment for malignant neoplasm not associated with the prostate gland",
            "criterions": [
                {
                    "exact_snippets": "malignant neoplasm not associated with the prostate gland",
                    "criterion": "malignant neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "association",
                            "expected_value": "not associated with the prostate gland"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participating in another clinical trial",
            "criterions": [
                {
                    "exact_snippets": "Participating in another clinical trial",
                    "criterion": "participation in another clinical trial",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lack of informed consent to participate in the study",
            "criterions": [
                {
                    "exact_snippets": "Lack of informed consent to participate in the study",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age <18 years",
            "criterions": [
                {
                    "exact_snippets": "Age <18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}