[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646917":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":137,"centralContacts":141,"locations":147,"responsibleParty":168,"collaborators":170,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":176,"sex":182,"minAge":183,"maxAge":114,"enrollmentInfo":184,"targetDuration":114,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":114,"overallStatus":194,"whyStopped":114,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"University of Michigan Rogel Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation (Lu-177-PSMA-617)","EXPERIMENTAL","Patients receive Lu-177-PSMA-617 IV on day 1 of each cycle.\n\nDose escalation will occur in cycle 1 only: Level 1: 14.8 GBq (7.4 GBq administered 2 times, 2 days apart) Level 2: 22.2 GBq (7.4 GBq administered 3 times, each 2 days apart)\n\nCycles repeat every 6 weeks for up to 5 cycles for dose level 1 and up to 4 cycles for dose level 2, with the Lu-177-PSMA-617 dose of 7.4 GBq, in the absence of disease progression or unacceptable toxicity. Patients also undergo SPECT\u002FCT scans and receive Ga-68 PSMA-11 and undergo PET\u002FCT after cycle 1.",[13,14,15,16,17,18,19,20],"Procedure: Biospecimen Collection","Procedure: Computed Tomography","Other: Gallium Ga 68 Gozetotide","Drug: Lutetium Lu 177 Vipivotide Tetraxetan","Device: Positron Emission Tomography","Other: Questionnaire Administration","Device: Single Photon Emission Computed Tomography","Other: Technetium Tc-99m Sulfur Colloid",[22,32,49,81,97,110,115,130],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Biospecimen Collection","Undergo collection of urine samples",[9],[28,29,30,31],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Computed Tomography","Undergo SPECT\u002FCT",[9],[37,38,39,40,41,42,43,44,45,46,47,48],"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":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Gallium Ga 68 Gozetotide","Given Ga-68 PSMA-11",[9],[54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"(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":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"DRUG","Lutetium Lu 177 Vipivotide Tetraxetan","Given IV",[9],[87,88,89,90,91,92,93,94,95,96],"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":98,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"DEVICE","Positron Emission Tomography","Undergo PET",[9],[103,104,105,106,107,108,109],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT",{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":114},"Questionnaire Administration","Ancillary studies",[9],null,{"type":98,"name":116,"description":34,"armGroupLabels":117,"otherNames":118},"Single Photon Emission Computed Tomography",[9],[119,120,121,122,123,124,125,126,127,128,129],"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",{"type":6,"name":131,"description":84,"armGroupLabels":132,"otherNames":133},"Technetium Tc-99m Sulfur Colloid",[9],[134,135,136],"Tc 99m Sulfur Colloid","Tc-99m SC","Technetium Tc 99m Sulfur Colloid",[138],{"name":139,"affiliation":5,"role":140},"Kirk A Frey, MD","PRINCIPAL_INVESTIGATOR",[142],{"name":143,"role":144,"phone":145,"phoneExt":114,"email":146},"Cancer AnswerLine","CONTACT","1-800-865-1125","CancerAnswerLine@med.umich.edu",[148],{"facility":5,"status":114,"city":149,"state":150,"zip":151,"country":152,"countryCode":153,"cosmosGeoPoint":154,"geoPoint":159,"contacts":160},"Ann Arbor","Michigan","48109","United States","US",{"type":155,"coordinates":156},"Point",[157,158],-83.74088,42.27756,{"lat":158,"lon":157},[161,163,165],{"name":143,"role":144,"phone":162,"phoneExt":114,"email":146},"800-865-1125",{"name":164,"role":140,"phone":114,"phoneExt":114,"email":114},"Kirk A. Frey, MD",{"name":166,"role":167,"phone":114,"phoneExt":114,"email":114},"Yuni Dewaraja, PhD","SUB_INVESTIGATOR",{"type":169,"investigatorFullName":114,"investigatorTitle":114,"investigatorAffiliation":114,"oldNameTitle":114,"oldOrganization":114},"SPONSOR",[171],{"name":172,"class":173},"National Cancer Institute (NCI)","NIH","100646917","phase-1-escalating-cycle-1-dose-of-lu-177-psma-617-for-the-treatment-of-metastatic-castration-resistant-prostate-cancer-100646917",false,"NCT07682649","Escalating Cycle 1 Dose of Lu-177-PSMA-617 for the Treatment of Metastatic Castration Resistant Prostate Cancer","A Phase 1 Study to Investigate Safety of Escalating Cycle 1 Dose of Lu-177-PSMA-617 Radioligand Therapy (RLT) in Metastatic Castration Resistant Prostate Cancer (mCRPC): The ESCENDO Trial","ESCENDO","Inclusion Criteria:\n\n* Patients must be eligible for standard Lu-177-PSMA617 RLT for mCRPC, including PSMA PET\u002FCT scan positive (lesion uptake \\> liver uptake by visual assessment)\n* Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e., prior chemotherapy, external beam radiation, brachytherapy, immunotherapy, etc.)\n* Patients must be ≥18 years of age\n* Patients must have an ECOG performance status of 0 or 1\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3\n* Platelet count ≥ 150,000\u002Fmm\\^3\n* Hemoglobin ≥ 10.0 g\u002FdL\n* Estimated glomerular filtration rate (EGFR) ≥ 60ml\u002Fmin\n* Bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases\n* Albumin \\> 3.0 g\u002FdL\n* Use effective birth control methods during the treatment and for 14 weeks after the last Lu-177-PSMA-617 dose\n* Ability to understand and the willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Does not meet criteria for standard Lu-177-PSMA-617 RLT\n* Diffuse marrow involvement evident on Ga-68-PSMA PET\u002FCT as assessed by study treating clinician\n* Prior RLT\n* Unmanageable concurrent bladder outflow obstruction or urinary incontinence\n* Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation\n* Plan to start any additional anti-cancer therapy or investigational agents during study therapy. Anti-cancer therapies include chemotherapy and endocrine therapy\n* Exclusion criteria for participation in other investigational trials: should not participate during RLT or 30 days prior to start of RLT","ALL","18 Years",{"count":185,"type":186},20,"ESTIMATED","INTERVENTIONAL",[189],"PHASE1","This phase I trial studies the safety, side effects, and treatment cycle 1 best dose of Lu-177-PSMA-617 in patients with prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant) and has spread from where it first started (primary site) to other places in the body (metastatic). Lu-177-PSMA-617 is a radioactive drug. It binds to a protein called prostate-specific membrane antigen (PSMA), which is found on prostate cancer tumor cells. Lu-177-PSMA-617 gives off radiation that may kill these tumor cells. It is a type of radioconjugate. Lu-177-PSMA-617 is currently used in a series of 6 intravenous infusions of the standard dosage, each separated by 6 weeks from the previous infusion. Investigators have observed that the first therapy administration (cycle 1) delivers better radiation treatment to the cancer than each of the following 5 infusions. Giving an increased dosage of Lu-177-PSMA-617 in treatment cycle 1 may have a better effect on metastatic castration-resistant prostate cancer than the standard dosage. The study does not change the total cumulative activity from what is used in the standard dosage treatment but gives an increased dosage in cycle 1 and reduces the total number of cycles.",[192,193],"Metastatic Castration-Resistant Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8","NOT_YET_RECRUITING","2026-06-26",{"date":197,"type":198},"2026-07-06","ACTUAL",{"date":200,"type":186},"2026-08-01",{"date":202,"type":186},"2031-08",{"name":5,"class":6},1]