protocolSection identificationModule nctId: NCT06288113, orgStudyIdInfo id: 23-001509, secondaryIdInfos id: NCI-2024-00310, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 23-001509, type: OTHER, domain: UCLA / Jonsson Comprehensive Cancer Center, briefTitle: Re-treatment With 177Lu-PSMA-617 for the Treatment of Metastatic Castration-Resistant Prostate Cancer, RE-LuPSMA Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-01-27, completionDateStruct date: 2027-01-27, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, collaborators name: Novartis Pharmaceuticals, descriptionModule briefSummary: This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer., conditionsModule conditions: Castration-Resistant Prostate Carcinoma, conditions: Stage IVB Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Gallium Ga 68 Gozetotide, interventions name: Lutetium Lu 177 Vipivotide Tetraxetan, interventions name: Positron Emission Tomography, interventions name: Questionnaire Administration, interventions name: Single Photon Emission Computed Tomography, outcomesModule primaryOutcomes measure: 12-month overall survival, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Rate of prostate specific antigen (PSA) response, secondaryOutcomes measure: Biochemical progression-free survival (PFS), secondaryOutcomes measure: Overall Survival from start of first regimen, secondaryOutcomes measure: Overall survival from the end of the first regimen, secondaryOutcomes measure: Radiographic progression-free survival (rPFS), secondaryOutcomes measure: Bone Pain, secondaryOutcomes measure: Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT)., secondaryOutcomes measure: Changes in health-related quality of life_Brief Pain Inventory Short form, secondaryOutcomes measure: Changes in health-related quality of life_ Eastern Cooperative Oncology Group score, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Ethan Lam, role: CONTACT, phone: 310-206-7372, email: clam@mednet.ucla.edu, contacts name: Stephanie Lira, role: CONTACT, phone: 3102060596, email: StephanieLira@mednet.ucla.edu, contacts name: Jeremie Calais, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False