[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531461":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":149,"centralContacts":132,"locations":154,"responsibleParty":175,"collaborators":132,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":132,"eligibilityCriteria":183,"healthyVolunteers":179,"sex":184,"minAge":185,"maxAge":132,"enrollmentInfo":186,"targetDuration":132,"studyType":189,"phases":190,"briefSummary":192,"conditions":193,"keywords":132,"overallStatus":156,"whyStopped":132,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":205},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm I (177Lu-PSMA-617 standard)","ACTIVE_COMPARATOR","Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients with a near complete response may receive 1 additional cycle. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET\u002FCT and a bone scan during screening and on the trial. Patients also undergo SPECT\u002FCT and blood sample collection on the trial.",[13,14,15,16,17,18,19,20],"Procedure: Biospecimen Collection","Procedure: Bone Scan","Procedure: Computed Tomography","Other: Gallium Ga 68 Gozetotide","Drug: Lutetium Lu 177 Vipivotide Tetraxetan","Procedure: Positron Emission Tomography","Other: Questionnaire Administration","Procedure: Single Photon Emission Computed Tomography",{"label":22,"type":23,"description":24,"interventionNames":25},"Arm II (177Lu-PSMA-617 treatment pause)","EXPERIMENTAL","Patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 5 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo clinical observation until documented first progression. After progression, patients resume treatment with 77Lu-PSMA-617 for another cycle. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET\u002FCT and a bone scan during screening and on the trial. Patients also undergo SPECT\u002FCT and blood sample collection on the trial.",[13,14,26,15,16,17,18,19,20],"Other: Clinical Observation",{"label":28,"type":23,"description":29,"interventionNames":30},"Arm III (Treatment pause 177Lu-PSMA-617)","Patients undergo clinical observation until documented first progression. After progression, patients receive 177Lu-PSMA-617 IV over 10-15 minutes on day 1 of each cycle. Cycles repeat every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo PET\u002FCT and a bone scan during screening and on the trial. Patients also undergo SPECT\u002FCT and blood sample collection on the trial.",[13,14,26,15,16,17,18,19,20],[32,41,47,53,68,100,115,128,133],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,22,28],[38,39,40],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Bone Scan","Undergo bone scan",[9,22,28],[46],"Bone Scintigraphy",{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Clinical Observation","Undergo active monitoring",[22,28],[52],"observation",{"type":33,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Computed Tomography","Undergo SPECT\u002FCT or PET\u002FCT",[9,22,28],[58,59,60,61,62,63,64,65,66,67],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography","Computerized Tomography (CT) scan",{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Gallium Ga 68 Gozetotide","Given IV",[9,22,28],[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC","(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","(68Ga)Glu-urea-Lys(Ahx)-HBED-CC","68Ga-DKFZ-PSMA-11","68Ga-HBED-CC-PSMA","68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC","68Ga-PSMA","68Ga-PSMA-11","68Ga-PSMA-HBED-CC","[68Ga] Prostate-specific Membrane Antigen 11","[68Ga]GaPSMA-11","AAA 517","AAA-517","AAA517","Ga PSMA","Ga-68 labeled DKFZ-PSMA-11","Ga-68 labeled PSMA-11","GA-68 PSMA-11","Gallium Ga 68 PSMA-11","Gallium Ga 68-labeled PSMA-11","GALLIUM GA-68 GOZETOTIDE","Gallium-68 PSMA","Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC","GaPSMA","PSMA-HBED-CC GA-68",{"type":101,"name":102,"description":70,"armGroupLabels":103,"otherNames":104},"DRUG","Lutetium Lu 177 Vipivotide Tetraxetan",[9,22,28],[105,106,107,108,109,110,111,112,113,114],"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":33,"name":116,"description":117,"armGroupLabels":118,"otherNames":119},"Positron Emission Tomography","Undergo PET\u002FCT",[9,22,28],[120,121,122,123,124,125,126,127],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":6,"name":129,"description":130,"armGroupLabels":131,"otherNames":132},"Questionnaire Administration","Ancillary studies",[9,22,28],null,{"type":33,"name":134,"description":135,"armGroupLabels":136,"otherNames":137},"Single Photon Emission Computed Tomography","Undergo SPECT\u002FCT",[9,22,28],[138,139,140,141,142,143,144,145,146,147,148],"Medical Imaging, Single Photon Emission Computed Tomography","Single Photon Emission Tomography","Single-Photon Emission Computed","single-photon emission computed tomography","SPECT","SPECT imaging","SPECT SCAN","SPET","ST","tomography, emission computed, single photon","Tomography, Emission-Computed, Single-Photon",[150],{"name":151,"affiliation":152,"role":153},"Matthew P. Thorpe, M.D., Ph.D.","Mayo Clinic in Rochester","PRINCIPAL_INVESTIGATOR",[155],{"facility":152,"status":156,"city":157,"state":158,"zip":159,"country":160,"countryCode":161,"cosmosGeoPoint":162,"geoPoint":167,"contacts":168},"RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":163,"coordinates":164},"Point",[165,166],-92.4699,44.02163,{"lat":166,"lon":165},[169,174],{"name":170,"role":171,"phone":172,"phoneExt":132,"email":173},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":151,"role":153,"phone":132,"phoneExt":132,"email":132},{"type":176,"investigatorFullName":132,"investigatorTitle":132,"investigatorAffiliation":132,"oldNameTitle":132,"oldOrganization":132},"SPONSOR","100531461","phase-2-schedule-de-escalation-of-177lu-psma-617-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-100531461",false,"NCT06200103","Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer","Minority-Inclusive Imaging Biomarker-Based End of Therapy Trial for 177Lu-PSMA-617, a Randomized De-Escalation Theranostic Trial for Metastatic Castrate Resistant Prostate Cancer","Inclusion Criteria:\n\n* REGISTRATION INCLUSION CRITERIA\n* Scheduled at Mayo Clinic Rochester for therapy with 177Lu PSMA-617\n* PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET will be considered equivalent for eligibility) , defined by molecular imaging prostate specific membrane antigen (miPSMA) score \\>= 2 on Mayo PET report, including interpretation of outside PET or consensus review of PET by nuclear therapy tumor board note in the patient chart\n* Willingness to provide mandatory blood draws for correlative research. (This requirement is waived for patients enrolling after receiving cycle 1 of 177Lu PSMA-617,and achieving a near complete response on post therapy SPECT, as these patients will not be able to provide a pre-treatment baseline blood sample.)\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* RANDOMIZATION INCLUSION CRITERIA\n* Lesions with uptake equal to or above liver on cycle 1 post therapy SPECT, demonstrating that a near complete response on follow up post-therapy scan represents response, rather than sensitivity differences between SPECT and pre-treatment PET\n* Near-complete response on post-therapy SPECT following any of cycles 2-5 of 177Lu PSMA-617. Near-complete response will be defined as no lesions with SUV max above the mean standard uptake value (SUV) of a representative 2cm spherical region of interest in the central right hepatic lobe, as determined by a nuclear medicine trained radiologist\n* No toxicity that would indicate withholding or reducing dose of the next scheduled cycle of 177Lu PSMA-617 per prescribing information\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL\n* Platelets ≥ 75,000\u002Fmm\\^3\n* Neutrophils ≥ 100\u002Fmm\\^3\n* Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin \\*body surface area (BSA) using Cockcroft-Gault formula OR\n* Creatinine ≤ 1.5 x upper limit of normal\n* Aspartate transferase (AST) or alanine transaminase (ALT) ≤ 3 x upper limit of normal\n* No other unacceptable toxicity in the clinical judgement of the investigators\n* RE-REGISTRATION INCLUSION CRITERIA (CROSSOVER TO COMPLETION UPON FIRST PROGRESSION OF PATIENTS RANDOMIZED TO TREATMENT PAUSE)\n* First progression in patients randomized to pause treatment\n* PSMA avid lesions on PSMA PET (miPSMA score ≥ 2 following first progression)\n\nExclusion Criteria:\n\n* REGISTRATION EXCLUSION CRITERIA\n* Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy\n* Receiving any other investigational agent which would be considered as a treatment for the prostate cancer\n* Failure to recover from acute, reversible effects of prior therapy regardless of interval since last treatment\n\n  * EXCEPTION: Grade 1 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment\n* Uncontrolled intercurrent non-cardiac illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Psychiatric illness\u002Fsocial situations\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that would limit compliance with study requirements\n* Any of the following because this study involves: An investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown\n\n  * Persons able to father a child who are unwilling to employ adequate contraception\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* RE-REGISTRATION EXCLUSION CRITERIA\n* Serious adverse effect","MALE","18 Years",{"count":187,"type":188},236,"ESTIMATED","INTERVENTIONAL",[191],"PHASE2","This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \\[PSMA\\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.",[194,195],"Castration-Resistant Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","2025-09-05",{"date":198,"type":199},"2025-09-11","ACTUAL",{"date":201,"type":199},"2024-05-03",{"date":203,"type":188},"2029-12-31",{"name":5,"class":6},1]