[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658459":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":85,"studyPopulation":81,"armGroups":86,"interventions":112,"overallOfficials":409,"centralContacts":81,"locations":81,"responsibleParty":414,"collaborators":416,"id":420,"slug":421,"hasResults":422,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":81,"eligibilityCriteria":426,"healthyVolunteers":422,"sex":427,"minAge":428,"maxAge":81,"enrollmentInfo":429,"targetDuration":81,"studyType":432,"phases":433,"briefSummary":436,"conditions":437,"keywords":81,"overallStatus":440,"whyStopped":81,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":81},{"fullName":5,"class":6},"Eastern Cooperative Oncology Group","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":67},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Second progression-free survival (PFS2) (Phase II)","Definition of progression includes radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Prostate Cancer Working Group 3 (PCWG3) for bone lesions, and clinical progression determined by treating physician. The phase II part will be conducted first and only if the treatment of Bipolar Androgen Therapy (BAT) followed by darolutamide significantly improves PFS2 compared to the SOC (SOC1 followed by SOC2) arm, then the study will continue to the phase III part. The primary comparisons will be an intention-to-treat analysis including all randomized patients. The phase II part of the study will have 89.5% power to detect the above difference in PFS2 using a one-sided 0.15 level stratified log-rank test.","From randomization to disease progression or death, whichever occurs first after initiation of second treatment (standard of care [SOC]2 or darolutamide), assessed up to 60 months",{"measure":14,"description":15,"timeFrame":16},"Overall survival (OS) (Phase III)","The phase II part will be conducted first and only if the treatment of BAT followed by darolutamide significantly improves PFS2 compared to the SOC (SOC1 followed by SOC2) arm, then the study will continue to the phase III part. The primary comparisons will be an intention-to-treat analysis including all randomized patients.","From randomization until death from any cause or date last known alive, assessed up to 60 months",{"measure":18,"description":19,"timeFrame":20},"Overall quality of life (QOL)","Will compare overall QOL, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between the two arms. Mixed-effects models will be constructed, utilizing all available data, with fixed effects for treatment arm, assessment time, and the treatment-by-time interactions. A random intercept per patient will be included to account for within-subject correlations.\n\nPatients will rate physical, social\u002Ffamily, emotional, and functional well-being along with additional concerns on a scale from \"not at all\" to \"very much\". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e.\"I am able to work\" rated as very much is not comparable to \"I feel sad\" rated as very much).","At randomization,12, 24 and 48 weeks after randomization",[22,26,29,33,35,38,40,43,45,49,52,55,58,62,64,66],{"measure":23,"description":24,"timeFrame":25},"Progression-free survival (PFS)","Will be determined using RECIST 1.1 criteria (for soft tissue metastases) and PCWG3 criteria (for bone metastases). Will be evaluated for each of the two treatments in a given arm.","From randomization to disease progression or death, whichever occurs first prior to initiation of the second treatment of the study, assessed up to 60 months",{"measure":27,"description":24,"timeFrame":28},"PFS","From initiation of second treatment to disease progression, clinical progression, or death, whichever occurs first, assessed up to 60 months",{"measure":30,"description":31,"timeFrame":32},"Radiographic response rate","Will be determined using RECIST 1.1 criteria. Will be evaluated for each of the two treatments in a given arm.","From initial randomization up to 60 months",{"measure":30,"description":31,"timeFrame":34},"From initiation of second treatment up to 60 months",{"measure":36,"description":37,"timeFrame":32},"Prostate-specific antigen (PSA) decline ≥ 50% from baseline (PSA50) response","Will be evaluated for each of the two treatments in a given arm.",{"measure":39,"description":37,"timeFrame":34},"PSA50 response",{"measure":41,"description":37,"timeFrame":42},"PSA PFS","From initial randomization to PSA progression or date of last disease assessment prior to initiation of second treatment, assessed up to 60 months",{"measure":41,"description":37,"timeFrame":44},"From initiation of second treatment to PSA progression or date of last disease assessment, assessed up to 60 months",{"measure":46,"description":47,"timeFrame":48},"Overall QOL","Will compare overall QOL, measured by FACT-P total score, between the two arms at 12 weeks after randomization.\n\nPatients will rate physical, social\u002Ffamily, emotional, and functional well-being along with additional concerns on a scale from \"not at all\" to \"very much\". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e.\"I am able to work\" rated as very much is not comparable to \"I feel sad\" rated as very much).","At 12 weeks after randomization",{"measure":46,"description":50,"timeFrame":51},"A two-sample t test will be performed to compare the changes in FACT-P scores between the two arms.\n\nPatients will rate physical, social\u002Ffamily, emotional, and functional well-being along with additional concerns on a scale from \"not at all\" to \"very much\". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e.\"I am able to work\" rated as very much is not comparable to \"I feel sad\" rated as very much).","From baseline to 12 weeks after randomization",{"measure":46,"description":53,"timeFrame":54},"The FACT-P total scores at the time of first progression will be compared between the two arms.\n\nPatients will rate physical, social\u002Ffamily, emotional, and functional well-being along with additional concerns on a scale from \"not at all\" to \"very much\". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e.\"I am able to work\" rated as very much is not comparable to \"I feel sad\" rated as very much).","At the time of first progression",{"measure":46,"description":56,"timeFrame":57},"The FACT-P total scores at the time of second progression will be compared between the two arms.\n\nPatients will rate physical, social\u002Ffamily, emotional, and functional well-being along with additional concerns on a scale from \"not at all\" to \"very much\". Interpretation of higher vs. lower scores being better is dependent on which subsection is being scored (i.e.\"I am able to work\" rated as very much is not comparable to \"I feel sad\" rated as very much).","From date of randomization until the date of second documented progression or date of death from any cause, whichever came first, assessed up to 60 months.",{"measure":59,"description":60,"timeFrame":61},"Patient-reported fatigue","Will be evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and compared between the two arms using a two-sample t test. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.","12 weeks after randomization date",{"measure":59,"description":63,"timeFrame":51},"A two-sample t test will be performed to compare the changes in FACIT-Fatigue scores between the two arms. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.",{"measure":59,"description":65,"timeFrame":54},"Will be compared between the two arms. Mixed effect models will be constructed to estimate the time profile of FACIT-Fatigue assessments in the two arms and to evaluate treatment-by-time interactions. Assessment time will be considered as a continuous variable if there is a linear trend in FACIT-Fatigue assessments over time or a set of dummy variables if non-linear trend exists.",{"measure":59,"description":65,"timeFrame":57},[68,71,75],{"measure":69,"description":70,"timeFrame":16},"Estimates of the primary outcome treatment effect by sex","Will estimate the primary outcome treatment effect and the corresponding 95% confidence intervals (CIs) by sex.",{"measure":72,"description":73,"timeFrame":74},"Estimates of the primary outcome treatment effect by race","Will estimate the primary outcome treatment effect and the corresponding 95% CIs by race.","Up to 60 months",{"measure":76,"description":77,"timeFrame":74},"Estimates of the primary outcome treatment effect by ethnicity","Will estimate the primary outcome treatment effect and the corresponding 95% CIs by ethnicity.",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":81,"timePerspective":81,"maskingInfo":83},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":84,"maskingDescription":81,"whoMasked":81},"NONE","PRIMARY OBJECTIVES:\n\nI. To evaluate if BAT followed by darolutamide (Arm B) is associated with improved second progression-free survival (PFS2) post second treatment compared to physician's choice standard of care (SOC)1 followed by SOC2 (Arm A) in men with mCRPC who have progressed on prior androgen receptor pathway inhibitor (ARPI). (Phase II) II. To evaluate if BAT followed by darolutamide (Arm B) is associated with improved overall survival (OS) compared to physician's choice SOC1 followed by SOC2 (Arm A) in men with mCRPC who have progressed on prior ARPI. (Phase III) III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, between Arms A and B. (Quality of Life \\[QOL\\] objective)\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the radiographic progression-free survival (PFS) following initial randomization (Arm A SOC1 versus \\[vs\\] Arm B BAT) and following second treatment (Arm A SOC 2 vs Arm B darolutamide) as determined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (for soft tissue metastases) and Prostate Cancer Working Group 3\u002FPCWG3 criteria (for bone metastases).\n\nII. To evaluate the PSA50 response (PSA decline ≥ 50% from baseline) rate following initial randomization (Arm A SOC1 vs Arm B BAT) and following second treatment (Arm A SOC2 vs Arm B darolutamide).\n\nIII. To evaluate the radiographic response rate following initial randomization (Arm A SOC1 vs Arm B BAT) and following second treatment (Arm A SOC2 vs Arm B darolutamide) per RECIST 1.1 criteria.\n\nIV. To evaluate the incidence and severity of adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).\n\nV. To compare overall quality of life, measured by FACT-P total score, at 12 weeks between Arms A and B. (QOL objective) VI. To compare the change in overall QOL, measured by FACT-P total score, from baseline to 12 weeks between Arms A and B. (QOL objective) VII. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue \\[FACIT-Fatigue\\] scores) at 12 weeks between Arms A and B. (QOL objective) VIII. To compare patient-reported overall QOL (FACT-P scores), and fatigue (FACIT-Fatigue scores) between Arms A and B at the time of first and second disease progression. (QOL objective) IX. To characterize longitudinal change in overall QOL (FACT-P) and fatigue (FACIT-Fatigue between baseline and second disease progression in Arms A and B. (QOL objective)\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive an SOC1 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel intravenously (IV) every 21 days with or without prednisone; OR 2) Abiraterone acetate orally (PO) once daily (QD) with prednisone or methylprednisolone or dexamethasone; OR 3) Enzalutamide PO QD. SOC1 treatment continues in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive an SOC2 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) cabazitaxel IV every 21 days; OR 3) lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) IV every 6 weeks for 6 doses; OR 4) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 5) Enzalutamide PO QD. SOC2 treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI), bone imaging, and biospecimen collection throughout the study.\n\nARM B: Patients receive testosterone cypionate intramuscularly (IM) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive darolutamide PO twice daily (BID) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.\n\nAfter completion of study treatment, patients are followed every 3 months for 24 months from randomization and then every 6 months for 60 months from randomization.",[87,105],{"label":88,"type":89,"description":90,"interventionNames":91},"Arm A (SOC1, SOC2)","ACTIVE_COMPARATOR","Patients receive an SOC1 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 3) Enzalutamide PO QD. SOC1 treatment continues in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive an SOC2 treatment regimen per discretion of the patient and the treating provider: 1) Docetaxel IV every 21 days with or without prednisone; OR 2) cabazitaxel IV every 21 days; OR 3) 177Lu-PSMA-617 IV every 6 weeks for 6 doses; OR 4) Abiraterone acetate PO QD with prednisone or methylprednisolone or dexamethasone; OR 5) Enzalutamide PO QD. SOC2 treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.",[92,93,94,95,96,97,98,99,100,101,102,103,104],"Drug: Abiraterone Acetate","Procedure: Biospecimen Collection","Procedure: Bone Scan","Drug: Cabazitaxel","Procedure: Computed Tomography","Drug: Dexamethasone","Drug: Docetaxel","Drug: Enzalutamide","Drug: Lutetium Lu 177 Vipivotide Tetraxetan","Procedure: Magnetic Resonance Imaging","Drug: Methylprednisolone","Drug: Prednisone","Other: Questionnaire Administration",{"label":106,"type":107,"description":108,"interventionNames":109},"Arm B (testosterone cypionate, darolutamide)","EXPERIMENTAL","Patients receive testosterone cypionate IM on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression then receive darolutamide PO BID in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, bone imaging, and biospecimen collection throughout the study.",[93,94,96,110,101,104,111],"Drug: Darolutamide","Drug: Testosterone Cypionate",[113,127,137,143,159,176,188,258,268,277,291,311,346,393,398],{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"DRUG","Abiraterone Acetate","Given PO",[88],[119,120,121,122,123,124,125,126],"BR9004","BR9004-1","CB 7630","CB-7630","CB7630","JNJ-212082","Yonsa","Zytiga",{"type":128,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"PROCEDURE","Biospecimen Collection","Undergo biospecimen collection",[88,106],[133,134,135,136],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":128,"name":138,"description":139,"armGroupLabels":140,"otherNames":141},"Bone Scan","Undergo bone imaging",[88,106],[142],"Bone Scintigraphy",{"type":114,"name":144,"description":145,"armGroupLabels":146,"otherNames":147},"Cabazitaxel","Given IV",[88],[148,149,150,151,152,153,154,155,156,157,158],"Jevtana","RPR 116258A","RPR-116258A","RPR116258A","Taxoid XRP6258","TXD 258","TXD-258","TXD258","XRP 6258","XRP-6258","XRP6258",{"type":128,"name":160,"description":161,"armGroupLabels":162,"otherNames":163},"Computed Tomography","Undergo CT",[88,106],[164,165,166,167,168,169,170,171,172,173,174,175],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":114,"name":177,"description":116,"armGroupLabels":178,"otherNames":179},"Darolutamide",[106],[180,181,182,183,184,185,186,187],"Antiandrogen ODM-201","BAY 1841788","BAY-1841788","BAY1841788","Nubeqa","ODM 201","ODM-201","ODM201",{"type":114,"name":189,"description":190,"armGroupLabels":191,"otherNames":192},"Dexamethasone","Given dexamethasone",[88],[193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257],"Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Dxevo","Fluorodelta","Fortecortin","Gammacorten","Hemady","Hexadecadrol","Hexadrol","LenaDex","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex",{"type":114,"name":259,"description":145,"armGroupLabels":260,"otherNames":261},"Docetaxel",[88],[262,263,264,265,266,267],"Docecad","RP 56976","RP-56976","RP56976","Taxotere","Taxotere Injection Concentrate",{"type":114,"name":269,"description":116,"armGroupLabels":270,"otherNames":271},"Enzalutamide",[88],[272,273,274,275,276],"ASP9785","MDV 3100","MDV-3100","MDV3100","Xtandi",{"type":114,"name":278,"description":145,"armGroupLabels":279,"otherNames":280},"Lutetium Lu 177 Vipivotide Tetraxetan",[88],[281,282,283,284,285,286,287,288,289,290],"177Lu-labeled PSMA-617","177Lu-PSMA-617","AAA 617","AAA-617","AAA617","Lu177-PSMA-617","Lutetium Lu 177-PSMA-617","LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN","Lutetium-177-PSMA-617","Pluvicto",{"type":128,"name":292,"description":293,"armGroupLabels":294,"otherNames":295},"Magnetic Resonance Imaging","Undergo MRI",[88,106],[296,297,298,299,300,301,302,303,304,305,306,307,308,309,310],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":114,"name":312,"description":313,"armGroupLabels":314,"otherNames":315},"Methylprednisolone","Given methylprednisolone",[88],[316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345],"Adlone","Caberdelta M","DepMedalone","Depo Moderin","Depo-Nisolone","Duralone","Emmetipi","Esametone","Firmacort","Medlone 21","Medrate","Medrol","Medrol Veriderm","Medrone","Mega-Star","Meprolone","Methylprednisolonum","Metilbetasone Solubile","Metrocort","Metypresol","Metysolon","Predni-M-Tablinen","Prednilen","Radilem","Sieropresol","Solpredone","Summicort","Urbason","Veriderm Medrol","Wyacort",{"type":114,"name":347,"description":348,"armGroupLabels":349,"otherNames":350},"Prednisone","Given prednisone",[88],[351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392],".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone",{"type":394,"name":395,"description":396,"armGroupLabels":397,"otherNames":81},"OTHER","Questionnaire Administration","Ancillary studies",[88,106],{"type":114,"name":399,"description":400,"armGroupLabels":401,"otherNames":402},"Testosterone Cypionate","Given IM",[106],[403,404,405,406,407,408],"depAndro","Depo-Testosterone","Depotest","Depovirin","Pertestis","Virilon",[410],{"name":411,"affiliation":412,"role":413},"Michael Schweizer","ECOG-ACRIN Cancer Research Group","PRINCIPAL_INVESTIGATOR",{"type":415,"investigatorFullName":81,"investigatorTitle":81,"investigatorAffiliation":81,"oldNameTitle":81,"oldOrganization":81},"SPONSOR",[417],{"name":418,"class":419},"National Cancer Institute (NCI)","NIH","100658459","phase-2-testing-the-use-of-high-dose-testosterone-followed-by-darolutamide-compared-to-the-usual-care-for-patients-with-metastatic-prostate-cancer-100658459",false,"NCT07852195","Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate Cancer","A Randomized Phase II\u002FIII Trial Evaluating Bipolar Androgen Therapy Followed by Darolutamide vs. Standard of Care in Patients With Metastatic Castration Resistant Prostate Cancer","Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Patient must have documented histologically confirmed adenocarcinoma of the prostate\n* Patient must have evidence of metastatic castration resistant prostate cancer (mCRPC) defined by Prostate Cancer Working Group 3 criteria as follows:\n\n  * Prostate-specific antigen (PSA) progression defined as PSA ≥ 2 ng\u002FmL and rising on two successive measurements at least 14 days apart (most recent PSA value must be within 28 days prior to randomization) AND\n  * Castrate serum testosterone level ≤ 50 ng\u002FdL\n* Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g., \"burst\", which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal, intra-articular and\u002For topical steroids are eligible\n* Patients must have progressed on prior androgen receptor pathway inhibitors (ARPI) including, but not limited to, abiraterone, enzalutamide, apalutamide, or darolutamide. There must be at least a 2-week washout period after stopping ARPI prior to randomization\n\n  * NOTE: Prior bicalutamide is allowed and does not count as an ARPI\n* Patient must not have prior chemotherapy for the treatment of mCRPC. Patient may have received docetaxel for the treatment of hormone-sensitive prostate cancer\n\n  * NOTE: This includes high dose testosterone therapy for prostate cancer\n* Patient must have at least one lesion (measurable and\u002For non-measurable) that can be accurately assessed at baseline by CT, MRI and\u002For bone scan and is suitable for repeated assessment. Baseline imaging must be obtained within 28 days prior to randomization\n* Patient must not have current cancer-related pain requiring the use of opiates at the time of randomization\n* Patient must not have received any systemic therapy or radiotherapy within 14 days prior to randomization\n\n  * NOTE: Luteinizing hormone-releasing hormone (LHRH) agonist\u002Fantagonist treatment is allowed\n* Patient must not have evidence of disease that, in the opinion of the investigator, would put the patient at risk from testosterone therapy (i.e., femoral metastases with concern over fracture risk, spinal or epidural metastases with concern over spinal cord compression)\n* Patient must not have tumor causing urinary outlet obstruction that requires self-catheterization for voiding. Patients with indwelling catheter (e.g., foley or suprapubic catheter) for urinary obstruction are eligible. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes are eligible\n* Patient must not have prior history of deep venous thrombosis or pulmonary embolism within 5 years prior to randomization unless they are receiving therapeutic anticoagulation\n* Patient must not expect to father children by using accepted and effective method(s) of contraception or by abstaining from heterosexual intercourse for the duration of their participation in this study treatment and for four months after the last dose of Arm A protocol treatment and for 3 months after the last dose of Arm B protocol treatment\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Hemoglobin (Hgb) \\> 7 g\u002FdL and \\\u003C 17 g\u002FdL (obtained ≤ 14 days prior to protocol randomization)\n* Leukocytes ≥ 3,000\u002Fmm\\^3 (obtained ≤ 14 days prior to protocol randomization)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (obtained ≤ 14 days prior to protocol randomization)\n* Platelets ≥ 100,000\u002Fmm\\^3 (obtained ≤ 14 days prior to protocol randomization)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN (obtained ≤ 14 days prior to protocol randomization)\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m\\^2 (obtained ≤ 14 days prior to protocol randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients 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* Patients 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, patients should be class 2 or better\n* Patient must be English or Spanish speaking to be eligible for the QOL component of the study\n\n  * NOTE: Sites cannot translate the associated QOL forms","ALL","18 Years",{"count":430,"type":431},432,"ESTIMATED","INTERVENTIONAL",[434,435],"PHASE2","PHASE3","This phase II\u002FII trial compares the effect of high dose testosterone followed by darolutamide with the usual care in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant). Usual care treatment for patients with metastatic prostate cancer includes surgery or medical castration which involves drugs to suppress the function of the testes. After receiving this therapy, a period of disease stability occurs, followed typically by cancer regrowth and castration-resistant disease. Castration-resistant prostate cancer occurs because the tumor cells are eventually able to adapt to the very low levels of testosterone in the body. A new type of therapy called Bipolar Androgen Therapy (BAT) involves giving patients very high doses of testosterone every 28 days. This results in a cycle of higher than normal testosterone levels (i.e., \"supraphysiologic\") to near castrate levels over the 28 days. BAT may be able to stop prostate tumor cells from becoming castrate-resistant. In this trial, patients who receive BAT with high dose testosterone and experience disease progression then receive darolutamide. Darolutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Adding BAT with high dose testosterone prior to darolutamide after disease progression may help shrink or stabilize metastatic castration-resistant prostate cancer better than usual treatments alone.",[438,439],"Metastatic Castration-Resistant Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2026-09-28",{"date":443,"type":444},"2026-10-01","ACTUAL",{"date":446,"type":431},"2027-01-06",{"date":448,"type":431},"2030-03-31",{"name":412,"class":6}]