{
    "info": {
        "nct_id": "NCT05869682",
        "official_title": "Phase 2 Study of Bright White Light During Treatment With ADT Combination Therapy in Men With Advanced Prostate Cancer to PreServe PHysIcal and MeNtal HEalth (SHINE)",
        "inclusion_criteria": "* Participants must have histologically or cytologically confirmed prostate cancer\n* Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 10 mm ( >= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI), or metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan. Alternatively patients may have radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan\n* Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy). Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed\n* Age >= 60 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =< 2\n* Expected time to next treatment of >= 12 months and life expectancy of >= 18 months, as determined by a study Investigator\n* Leukocytes >= 3,000/mcL\n* Absolute neutrophil count >= 1,500/mcL\n* Platelets >= 100,000/mcL\n* Total bilirubin =< institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN\n* Creatinine =< institutional ULN OR\n* Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better\n* Ability to understand and the willingness to sign a written informed consent document\n* Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if they discontinue treatment due to cancer progression, they should not continue on the protocol\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 60 Years",
        "exclusion_criteria": "* Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is < 12 months\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia\n* Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide\n* Participants who are receiving any other investigational agents\n* Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study\n* Histologic evidence of small cell prostate cancer\n* Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months\n* Uncontrolled pain related to prostate cancer or separate chronic condition\n* Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of < 18 months\n* Participants with uncontrolled intercurrent illness\n* Concurrent second active malignancy\n* Severe sleep disorders (e.g. Narcolepsy)\n* Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)\n* Severe psychological impairment (e.g., bipolar disorder or manic episodes)\n* Current employment in night shift work\n* Previous use of light therapy to alleviate fatigue or depressive symptoms\n* Currently recovering from previous eye surgery within the past 6 months that causes eye irritation\n* Sensitivity to light, epilepsy, or a history of seizures",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have histologically or cytologically confirmed prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed prostate cancer",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants must have radiographic evidence of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 10 mm ( >= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI), or metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan. Alternatively patients may have radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan",
            "criterions": [
                {
                    "exact_snippets": "radiographic evidence of measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one lesion that can be accurately measured in at least one dimension",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions",
                    "criterion": "lesion measurement",
                    "requirements": [
                        {
                            "requirement_type": "measurement method",
                            "expected_value": [
                                "longest diameter for non-nodal lesions",
                                "short axis for nodal lesions"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "as >= 10 mm ( >= 1 cm) with computed tomography (CT) scan or magnetic resonance imaging (MRI)",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic lesions as identified as related to prostate cancer on a standard technetium bone scan",
                    "criterion": "metastatic lesions",
                    "requirements": [
                        {
                            "requirement_type": "identification method",
                            "expected_value": "standard technetium bone scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "radiographic evidence of metastatic disease on an Axumin or prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) scan",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence method",
                            "expected_value": [
                                "Axumin PET scan",
                                "PSMA-PET scan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer) plus abiraterone acetate and prednisone or darolutamide (triplet therapy), or ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy). Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed",
            "criterions": [
                {
                    "exact_snippets": "Eligible for treatment with ADT plus docetaxel (planned for 6 cycles or fewer)",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "ADT",
                                "docetaxel"
                            ]
                        },
                        {
                            "requirement_type": "treatment plan",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "cycles"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible for treatment with ... abiraterone acetate and prednisone or darolutamide (triplet therapy)",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "abiraterone acetate",
                                "prednisone",
                                "darolutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Eligible for treatment with ... ADT plus enzalutamide, apalutamide, or darolutamide (doublet therapy)",
                    "criterion": "treatment eligibility",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "ADT",
                                "enzalutamide",
                                "apalutamide",
                                "darolutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior use of ADT with a gonadotropin hormone-releasing hormone (GnRH) agonist or antagonist, or prior orchiectomy is allowed",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "ADT with GnRH agonist",
                                "ADT with GnRH antagonist",
                                "orchiectomy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age >= 60 years",
            "criterions": [
                {
                    "exact_snippets": "Age >= 60 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status =< 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status =< 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Expected time to next treatment of >= 12 months and life expectancy of >= 18 months, as determined by a study Investigator",
            "criterions": [
                {
                    "exact_snippets": "Expected time to next treatment of >= 12 months",
                    "criterion": "time to next treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of >= 18 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes >= 3,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes >= 3,000/mcL",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count >= 1,500/mcL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count >= 1,500/mcL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets >= 100,000/mcL",
            "criterions": [
                {
                    "exact_snippets": "Platelets >= 100,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mcL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin =< institutional upper limit of normal (ULN)",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin =< institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) ... =< 3 x institutional ULN",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) ... =< 3 x institutional ULN",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine =< institutional ULN OR",
            "criterions": [
                {
                    "exact_snippets": "Creatinine =< institutional ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "institutional ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2",
            "criterions": [
                {
                    "exact_snippets": "Glomerular filtration rate (GFR) >= 50 mL/min/1.73 m^2",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min/1.73 m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)-infected",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "effective anti-retroviral therapy",
                    "criterion": "anti-retroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable viral load within 6 months",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated",
            "criterions": [
                {
                    "exact_snippets": "evidence of chronic hepatitis B virus (HBV) infection",
                    "criterion": "chronic hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HBV viral load must be undetectable",
                    "criterion": "HBV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "on suppressive therapy, if indicated",
                    "criterion": "suppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "indication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load",
            "criterions": [
                {
                    "exact_snippets": "history of hepatitis C virus (HCV) infection",
                    "criterion": "history of hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "treated and cured"
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV infection ... currently on treatment ... undetectable HCV viral load",
                    "criterion": "current HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "currently on treatment"
                        },
                        {
                            "requirement_type": "viral load",
                            "expected_value": "undetectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial",
            "criterions": [
                {
                    "exact_snippets": "prior or concurrent malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "natural history or treatment does not have the potential to interfere with the safety or efficacy assessment",
                    "criterion": "interference with safety or efficacy assessment",
                    "requirements": [
                        {
                            "requirement_type": "potential to interfere",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better",
            "criterions": [
                {
                    "exact_snippets": "known history or current symptoms of cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history or symptoms",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of treatment with cardiotoxic agents",
                    "criterion": "treatment with cardiotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical risk assessment of cardiac function using the New York Heart Association Functional Classification ... class 2B or better",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "New York Heart Association Functional Classification",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "ability to understand",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants are still eligible and may proceed with the protocol and bright white light therapy if they discontinue baseline hormonal treatment, but plan to continue with another of the eligible treatments. However, if they discontinue treatment due to cancer progression, they should not continue on the protocol",
            "criterions": [
                {
                    "exact_snippets": "discontinue baseline hormonal treatment",
                    "criterion": "baseline hormonal treatment",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plan to continue with another of the eligible treatments",
                    "criterion": "eligible treatments",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "discontinue treatment due to cancer progression",
                    "criterion": "cancer progression",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "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 60 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 60 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participants receiving docetaxel cannot have metastatic castration-resistant prostate cancer as the expected median time to progression to next therapy is < 12 months",
            "criterions": [
                {
                    "exact_snippets": "Participants receiving docetaxel",
                    "criterion": "docetaxel treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cannot have metastatic castration-resistant prostate cancer",
                    "criterion": "metastatic castration-resistant prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "expected median time to progression to next therapy is < 12 months",
                    "criterion": "median time to progression to next therapy",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia",
            "criterions": [
                {
                    "exact_snippets": "Participants who have not recovered from adverse events due to prior anti-cancer therapy",
                    "criterion": "recovery from adverse events due to prior anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual toxicities > grade 1",
                    "criterion": "residual toxicities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "exception of alopecia",
                    "criterion": "alopecia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide for participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with combination hormonal therapy with abiraterone acetate, enzalutamide, apalutamide, or darolutamide",
                    "criterion": "prior treatment with combination hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "abiraterone acetate",
                                "enzalutamide",
                                "apalutamide",
                                "darolutamide"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "participants planning to start treatment with abiraterone acetate, enzalutamide, apalutamide, or darolutamide",
                    "criterion": "planned treatment",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "abiraterone acetate",
                                "enzalutamide",
                                "apalutamide",
                                "darolutamide"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are receiving any other investigational agents",
            "criterions": [
                {
                    "exact_snippets": "Participants who are receiving any other investigational agents",
                    "criterion": "receiving investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with brain metastases are ineligible due to the limited life expectancy of men with prostate cancer metastases to brain",
            "criterions": [
                {
                    "exact_snippets": "brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study",
                    "criterion": "allergic reactions",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "attribution",
                            "expected_value": "compounds of similar chemical or biologic composition to agents used in this study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologic evidence of small cell prostate cancer",
            "criterions": [
                {
                    "exact_snippets": "Histologic evidence of small cell prostate cancer",
                    "criterion": "small cell prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "evidence type",
                            "expected_value": "histologic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptomatic skeletal event complication of prostate cancer such as cord compression, fracture, or need for radiation or surgery to a bone lesion within 6 months",
            "criterions": [
                {
                    "exact_snippets": "Symptomatic skeletal event complication of prostate cancer such as cord compression",
                    "criterion": "skeletal event complication",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fracture",
                    "criterion": "fracture",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "need for radiation or surgery to a bone lesion",
                    "criterion": "need for radiation or surgery to a bone lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within 6 months",
                    "criterion": "time frame for skeletal event",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled pain related to prostate cancer or separate chronic condition",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled pain related to prostate cancer",
                    "criterion": "pain related to prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled pain related to ... separate chronic condition",
                    "criterion": "pain related to separate chronic condition",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Visceral crisis from prostate cancer suggesting rapidly progressive disease and life expectancy of < 18 months",
            "criterions": [
                {
                    "exact_snippets": "Visceral crisis from prostate cancer",
                    "criterion": "visceral crisis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "suggesting rapidly progressive disease",
                    "criterion": "rapidly progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "suggestion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "life expectancy of < 18 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with uncontrolled intercurrent illness",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled intercurrent illness",
                    "criterion": "intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent second active malignancy",
            "criterions": [
                {
                    "exact_snippets": "Concurrent second active malignancy",
                    "criterion": "second active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe sleep disorders (e.g. Narcolepsy)",
            "criterions": [
                {
                    "exact_snippets": "Severe sleep disorders (e.g. Narcolepsy)",
                    "criterion": "sleep disorders",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eye Diseases which limit the ability of light to be processed (e.g. untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or other retinal disorder)",
            "criterions": [
                {
                    "exact_snippets": "Eye Diseases which limit the ability of light to be processed",
                    "criterion": "eye diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "limit the ability of light to be processed"
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated cataracts",
                    "criterion": "cataracts",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe glaucoma",
                    "criterion": "glaucoma",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "macular degeneration",
                    "criterion": "macular degeneration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blindness",
                    "criterion": "blindness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pupil dilation problems",
                    "criterion": "pupil dilation problems",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other retinal disorder",
                    "criterion": "retinal disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe psychological impairment (e.g., bipolar disorder or manic episodes)",
            "criterions": [
                {
                    "exact_snippets": "Severe psychological impairment (e.g., bipolar disorder or manic episodes)",
                    "criterion": "psychological impairment",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "bipolar disorder",
                                "manic episodes"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current employment in night shift work",
            "criterions": [
                {
                    "exact_snippets": "Current employment in night shift work",
                    "criterion": "employment in night shift work",
                    "requirements": [
                        {
                            "requirement_type": "current status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous use of light therapy to alleviate fatigue or depressive symptoms",
            "criterions": [
                {
                    "exact_snippets": "Previous use of light therapy",
                    "criterion": "light therapy",
                    "requirements": [
                        {
                            "requirement_type": "previous use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alleviate fatigue",
                    "criterion": "fatigue",
                    "requirements": [
                        {
                            "requirement_type": "alleviation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alleviate ... depressive symptoms",
                    "criterion": "depressive symptoms",
                    "requirements": [
                        {
                            "requirement_type": "alleviation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Currently recovering from previous eye surgery within the past 6 months that causes eye irritation",
            "criterions": [
                {
                    "exact_snippets": "Currently recovering from previous eye surgery",
                    "criterion": "recovery from eye surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "within the past 6 months",
                    "criterion": "time since eye surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "causes eye irritation",
                    "criterion": "eye irritation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sensitivity to light, epilepsy, or a history of seizures",
            "criterions": [
                {
                    "exact_snippets": "Sensitivity to light",
                    "criterion": "sensitivity to light",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "epilepsy",
                    "criterion": "epilepsy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of seizures",
                    "criterion": "history of seizures",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}