Nctid:
NCT06235151
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011471", "term"=>"Prostatic Neoplasms"}], "ancestors"=>[{"id"=>"D000005834", "term"=>"Genital Neoplasms, Male"}, {"id"=>"D000014565", "term"=>"Urogenital Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000005832", "term"=>"Genital Diseases, Male"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000011469", "term"=>"Prostatic Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}], "browseLeaves"=>[{"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M14335", "name"=>"Prostatic Neoplasms", "asFound"=>"Prostate Cancer", "relevance"=>"HIGH"}, {"id"=>"M8946", "name"=>"Genital Neoplasms, Male", "relevance"=>"LOW"}, {"id"=>"M17315", "name"=>"Urogenital Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M8944", "name"=>"Genital Diseases, Male", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14333", "name"=>"Prostatic Diseases", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003300", "term"=>"Copper"}], "ancestors"=>[{"id"=>"D000014131", "term"=>"Trace Elements"}, {"id"=>"D000018977", "term"=>"Micronutrients"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M6523", "name"=>"Copper", "asFound"=>"Dermal", "relevance"=>"HIGH"}, {"id"=>"M21258", "name"=>"Radiopharmaceuticals", "relevance"=>"LOW"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"T338", "name"=>"Copper Supplement", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Mineral", "abbrev"=>"Mi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"DIAGNOSTIC", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>323}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2025-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-07-02", "studyFirstSubmitDate"=>"2024-01-23", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-07", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Determine the relationship of Prostate Specific Antigen (PSA) level, Gleason score, and the diagnostic performance of copper Cu 64 PSMA I&T PET/CT", "timeFrame"=>"4 Hours", "description"=>"Correlation of sensitivity, specificity, detection rate, and Positive Predictive Value (PPV) to baseline PSA and unfavorable intermediate-risk, high-risk or very high-risk at the time of prostatectomy."}, {"measure"=>"Assess PPV of lesions on copper Cu 64 PSMA I&T PET/CT outside the prostate and pelvic lymph nodes (M1 disease)", "timeFrame"=>"4 Hours", "description"=>"Proportion of patients with M1 lesions on copper Cu 64 PSMA I\\&T PET/CT subsequently confirmed to be TP by biopsy, surgery and confirmatory imaging."}, {"measure"=>"Assess the impact of copper Cu 64 PSMA I&T PET/CT on the intended clinical management of study participants", "timeFrame"=>"4 Hours", "description"=>"Percentage of patients in whom the copper Cu 64 PSMA I\\&T PET/CT changed the intended patient management (major and other changes)."}, {"measure"=>"Assess the detection rate on patient level and split by pelvic lymph nodes and extra pelvic lesions", "timeFrame"=>"4 Hours", "description"=>"Patient level positivity rates of copper Cu 64 PSMA I\\&T split by pelvic lymph nodes and extra pelvic lesions."}, {"measure"=>"Determine sensitivity and specificity by risk group (unfavorable intermediate, high, or very high risk)", "timeFrame"=>"4 Hours", "description"=>"Determine the diagnostic performance of copper Cu 64 PSMA I\\&T PET/CT for the detection of presence or absence of pelvic lymph node metastasis in pre-prostatectomy patients by risk group (unfavorable intermediate, high, or very high risk)."}], "primaryOutcomes"=>[{"measure"=>"Sensitivity", "timeFrame"=>"4 Hours", "description"=>"Determine the presence of metastatic pelvic lymph nodes relative to histopathology reference standard. At least one positive pelvic lymph node on the PET scan and one positive lymph node as determined by histopathology on the same side of the pelvis (left or right) will be counted a true positive at the patient level."}, {"measure"=>"Specificity", "timeFrame"=>"4 Hours", "description"=>"Determine the absence of metastatic pelvic lymph nodes relative to histopathology reference standard. Negative pelvic lymph node on the PET scan and negative pelvic lymph nodes as determined by histopathology on the same side of the pelvis (Left or Right) will be counted a true negative at the patient level."}], "secondaryOutcomes"=>[{"measure"=>"Inter-reader and intra-reader agreement of copper Cu 64 PSMA I&T PET/CT interpretation on a per-patient basis", "timeFrame"=>"4 Hours", "description"=>"Reader kappa statistics of copper Cu 64 PSMA I\\&T PET/CT scan interpretation by the blinded independent readers."}, {"measure"=>"Incidence of adverse events in copper Cu 64 PSMA I&T injection", "timeFrame"=>"At time of dose administration up to 72 Hours", "description"=>"Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["PSMA", "Prostate Cancer", "Initial Staging", "Solar-Stage", "Cu-64 PSMA", "PET", "Solar"], "conditions"=>["Prostate Cancer", "Prostate Adenocarcinoma"]}, "descriptionModule"=>{"briefSummary"=>"This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.", "detailedDescription"=>"The study will include approximately 323 patients with newly diagnosed unfavorable intermediate high-risk, high-risk or veru high-risk prostate cancer electing to undergo radical prostatectomy with pelvic lymph node dissection. Each patient will be administered an 8 mCi (± 10 percent) intravenous dose of copper Cu 64 PSMA I\\&T injection. PET/CT imaging will be acquired for all patients at 1-4 hours ± 15 minutes post copper Cu 64 PSMA I\\&T injection.\n\nThe PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of lesions considered positive for Prostate Cancer (PC) in pelvic lymph nodes. Positive lesions in the prostate, extra pelvic lymph nodes, bones and soft tissue/viscera will also be recorded. Analysis of the reads will be used for determination of sensitivity and specificity of copper Cu 64 PSMA I\\&T PET/CT by comparison to the reference standard of histopathology after matching by hemipelvis with at least one true positive lesion defining a true positive patient. Detection of PC outside the pelvis on the copper Cu 64 PSMA I\\&T PET/CT will be assessed using reference standard of histopathology and if not available conventional imaging. Baseline conventional imaging will be reviewed for PC disease or no disease by independent radiology readers."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "genderBased"=>true, "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with histologically proven prostate adenocarcinoma.\n* Planned prostatectomy with pelvic lymph node dissection.\n* Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.\n* Male aged greater than or equal to 18 years.\n* Able to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.\n* Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.\n* Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.\n* Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.\n* Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\\&T administration.\n* Patients with known hypersensitivity to the active substance or any of the excipients of the IP.\n* Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment."}, "identificationModule"=>{"nctId"=>"NCT06235151", "acronym"=>"Solar-Stage", "briefTitle"=>"Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Curium US LLC"}, "officialTitle"=>"Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection", "orgStudyIdInfo"=>{"id"=>"CURCu64PSM0003"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Diagnostic Imaging with Copper Cu 64 PSMA I&T", "description"=>"Copper Cu 64 PSMA I\\&T Injection", "interventionNames"=>["Drug: Copper Cu 64 PSMA I&T"]}], "interventions"=>[{"name"=>"Copper Cu 64 PSMA I&T", "type"=>"DRUG", "description"=>"Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.", "armGroupLabels"=>["Diagnostic Imaging with Copper Cu 64 PSMA I&T"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"92835", "city"=>"Fullerton", "state"=>"California", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"Providence Medical Foundation", "geoPoint"=>{"lat"=>33.87029, "lon"=>-117.92534}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Tower Urology", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90073", "city"=>"Los Angeles", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"VA Greater Los Angeles Healthcare System", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92663", "city"=>"Newport Beach", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Hoag Memorial Hospital Presbyterian", "geoPoint"=>{"lat"=>33.61891, "lon"=>-117.92895}}, {"zip"=>"92868", "city"=>"Orange", "state"=>"California", "status"=>"NOT_YET_RECRUITING", "country"=>"United States", "facility"=>"University of California, Irvine", "geoPoint"=>{"lat"=>33.78779, "lon"=>-117.85311}}, {"zip"=>"33165", "city"=>"Miami", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"CIRA Health", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"33615", "city"=>"Tampa", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Florida Urology Partners", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"60141", "city"=>"Hines", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Edward Hines Jr. VA Hospital", "geoPoint"=>{"lat"=>41.85364, "lon"=>-87.8395}}, {"zip"=>"63104", "city"=>"Saint Louis", "state"=>"Missouri", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"SSM Health Saint Louis University Hospital", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"69101", "city"=>"North Platte", "state"=>"Nebraska", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Great Plains Health, Diagnostic Imaging", "geoPoint"=>{"lat"=>41.12389, "lon"=>-100.76542}}, {"zip"=>"68130", "city"=>"Omaha", "state"=>"Nebraska", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"XCancer", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"10532", "city"=>"Hawthorne", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Adaptive Research Inc.", "geoPoint"=>{"lat"=>41.10732, "lon"=>-73.79597}}, {"zip"=>"11432", "city"=>"Jamaica", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Queens Hospital Center", "geoPoint"=>{"lat"=>40.69149, "lon"=>-73.80569}}, {"zip"=>"37920", "city"=>"Knoxville", "state"=>"Tennessee", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"University of Tennessee Medical Center", "geoPoint"=>{"lat"=>35.96064, "lon"=>-83.92074}}, {"zip"=>"77042", "city"=>"Houston", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Excel Diagnostics and Nuclear Oncology Center", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"78229", "city"=>"San Antonio", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Urology San Antonio", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"78240", "city"=>"San Antonio", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"The Urology Place", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}], "centralContacts"=>[{"name"=>"Darcy Denner, PhD", "role"=>"CONTACT", "email"=>"SOLAR@curiumpharma.com", "phone"=>"314-660-4844"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Curium US LLC", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
