[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590838":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":36,"responsibleParty":55,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":38,"whyStopped":11,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Excel Diagnostics and Nuclear Oncology Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL",null,[13],"Drug: Administering Lutetium-177-PSMA-617 (PLUVICTO)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Administering Lutetium-177-PSMA-617 (PLUVICTO)","The study begins with a first cohort of three participants, each receiving a dose of 100 millicuries (mCi). After administration, participants are monitored for any dose-limiting toxicities (DLTs) during a predefined observation window. If fewer than two participants experience a DLT in a given cohort, the dose will be escalated for the next group. The dose escalation schedule is structured as follows: the second cohort receives 130 mCi (a 30% increase), the third cohort receives 162.5 mCi (a 25% increase), and the fourth cohort receives 200 mCi, a dose that is already FDA-approved and clinically accepted for mCRPC. This stepwise escalation continues until the 200 mCi dose is reached, or until two or more DLTs are observed in any cohort. If that occurs, escalation stops immediately, and the maximum tolerated dose is considered to be the previous lower dose. This becomes the optimal tolerated dose (OTD). After identifying the OTD, additional participants will be enrolled for treatment.",[9],[21],{"name":22,"affiliation":23,"role":24},"Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine","Excel Diagnostics & Nuclear Oncology Center","PRINCIPAL_INVESTIGATOR",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Susan Cork Therapy Coordinator","CONTACT","713-781-6200","3203","scork@exceldiagnostics.com",{"name":33,"role":28,"phone":29,"phoneExt":34,"email":35},"Nereyda Sauceda, Therapy Coordinator","3246","nsauceda@exceldiagnostics.com",[37],{"facility":23,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Houston","Texas","77042","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-95.36327,29.76328,{"lat":48,"lon":47},[51,52,53],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},{"name":33,"role":28,"phone":29,"phoneExt":34,"email":35},{"name":54,"role":24,"phone":11,"phoneExt":11,"email":11},"Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD.Nuclear Medicine",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Ebrahim S Delpassand","Chairman & Medical Director, Excel Diagnostics & Nuclear Oncology Center","100590838","phase-2-treatment-of-patients-with-progressive-mcrpc-with-177lu-psma-617-100590838",false,"NCT06972628","Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617","177Lu-PSMA-617 (Pluvicto) for the Treatment of Patients With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Super Scan Bone Scan","Inclusion Criteria:\n\n1. Ability to understand and sign an informed consent form (ICF).\n2. Willingness and ability to comply with study requirements.\n3. Age ≥18 years.\n4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP\u002FHDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n6. Hemoglobin ≥9.0 g\u002FdL.\n7. Platelet count ≥90 × 10⁹\u002FL.\n8. White blood cell count ≥2.0 × 10⁹\u002FL, absolute neutrophil count (ANC) \\>1.5 × 10⁹\u002FL.\n\n   o These hematologic criteria must be met without recent transfusions (within 28 days prior to the first study treatment) or growth factor support (within 21 days).\n9. Serum\u002Fplasma creatinine ≤1.5 × upper limit of normal (ULN).\n10. Histological, pathological, or cytological confirmation of prostate cancer.\n11. Positive PSMA PET\u002FCT scan showing at least one PSMA-positive metastatic lesion.\n12. Castrate-level serum\u002Fplasma testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL).\n13. Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT).\n\nExclusion Criteria:\n\n1. Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium- 186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol.\n2. Prior PSMA-targeted radioligand therapy.\n3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.\n4. Known hypersensitivity to PLUVICTO or its components.\n5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.\n6. Renal impairment (estimated glomerular filtration rate \\\u003C60 mL\u002Fmin), hemoglobin \\\u003C9 g\u002FdL, ANC \\\u003C1.5 × 10⁹\u002FL, or platelets \\\u003C 90 × 10⁹\u002FL.\n7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.\n8. Symptomatic or impending spinal cord compression.\n9. Other malignancies impacting life expectancy or interfering with study assessments. Exceptions include non-melanoma skin cancer or superficial bladder cancer that has been adequately treated.\n10. Major surgery within 30 days prior to enrollment.\n11. Plans to conceive or father a child during treatment and up to six months post-treatment.","MALE","18 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a \"super scan\" pattern on a bone scan.\n\nPluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap.\n\nThe study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose.\n\nThe safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population.\n\nThis study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.",[76,77,78,79,80],"Metastatic Castration-Resistant Prostate Cancer","Prostate Cancer Patients With Bone Metastasis","Prostate Cancer (CRPC)","Prostate Cancer","Prostate Cancer Metastatic",[82,83,84,85,86,87],"Metastatic Castration-Resistant Prostate Cancer (mCRPC)","super scan bone scan","Prostate Cancer patients with bone metastasis","prostate cancer (CRPC)","Prostate cancer","Prostate cancer metastatic","2025-05-12",{"date":90,"type":91},"2025-05-15","ACTUAL",{"date":93,"type":70},"2025-05-23",{"date":95,"type":70},"2029-04-01",{"name":57,"class":6},1]