[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659386":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":37,"studyPopulation":38,"armGroups":34,"interventions":39,"overallOfficials":34,"centralContacts":34,"locations":54,"responsibleParty":74,"collaborators":34,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":34,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":34,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":34,"briefSummary":91,"conditions":92,"keywords":34,"overallStatus":57,"whyStopped":34,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Lithuanian University of Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":34},[9,13],{"measure":10,"description":11,"timeFrame":12},"Prostate-specific antigen (PSA) response","PSA50 is defined for each participant as a decline in PSA concentration of 50% or more from baseline. Baseline PSA is measured before the first \\[177Lu\\]Lu-PSMA-617 cycle; the decline is measured to the nadir during treatment or within 3 months after the last cycle. The number of participants meeting this definition is reported.","From baseline to nadir during treatment or within 3 months after the last cycle (each cycle is 6 weeks, up to 6 cycles), up to 49 weeks.",{"measure":14,"description":15,"timeFrame":16},"Progression-free survival (PFS)","Time from the first \\[177Lu\\]Lu-PSMA-617 cycle to disease progression or death from any cause, whichever occurs first. Progression is determined by biochemical (PSA) and\u002For imaging (68Ga-PSMA PET\u002FCT) criteria. Participants who discontinue treatment for reasons unrelated to progression and have no documented progression are censored at the date of the last assessment.","From the first treatment cycle until disease progression or death from any cause, assessed up to 5 years (each cycle is 6 weeks, up to 6 cycles).",[18,22,26,30],{"measure":19,"description":20,"timeFrame":21},"Overall survival (OS)","Time from the first \\[177Lu\\]Lu-PSMA-617 cycle to death from any cause.","From the first treatment cycle until death from any cause, assessed up to 5 years (each cycle is 6 weeks, up to 6 cycles).",{"measure":23,"description":24,"timeFrame":25},"Number of participants in each imaging response category on 68Ga-PSMA PET\u002FCT as assessed by RECIP 1.0","Imaging response assessed by comparing baseline and follow-up 68Ga-PSMA PET\u002FCT. Each participant is classified by RECIP 1.0 as complete response, partial response, stable disease, or progressive disease, and the number of participants in each category is reported. Response is also classified in parallel by other standardized PSMA PET\u002FCT response assessment systems.","Baseline (before the first cycle) and approximately 4 to 8 weeks after the last treatment cycle (each cycle is 6 weeks, up to 6 cycles), up to 44 weeks.",{"measure":27,"description":28,"timeFrame":29},"Treatment-related adverse events","Treatment-related adverse events recorded during the study and graded according to CTCAE v6.0. The number of participants is reported by severity grade.","From the first treatment cycle until 4 to 6 weeks after the last cycle (each cycle is 6 weeks, up to 6 cycles), up to 42 weeks.",{"measure":31,"description":32,"timeFrame":33},"Change from baseline in health-related quality of life as assessed by the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)","Health-related quality of life measured with the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), validated Lithuanian version. The questionnaire covers eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Each domain is scored from 0 to 100, where higher scores indicate better health-related quality of life. Change from baseline is reported for each domain.","Baseline (Cycle 1, before infusion), Week 12 (Cycle 3), Week 24 (Cycle 5), and 4 to 8 weeks after the last cycle at the follow-up PET\u002FCT visit (each cycle is 6 weeks, up to 6 cycles), up to 38 weeks.",null,{"allocation":34,"interventionModel":34,"interventionModelDescription":34,"primaryPurpose":34,"observationalModel":36,"timePerspective":6,"maskingInfo":34},"COHORT","BACKGROUND AND RATIONALE Radioligand therapy (RLT) with \\[177Lu\\]Lu-PSMA-617 (Pluvicto) is an approved treatment for metastatic castration-resistant prostate cancer (mCRPC) after androgen receptor pathway inhibitors and taxane chemotherapy. In the VISION trial, a PSA decline of 50% or more was seen in only about 46% of patients. Baseline PSMA PET\u002FCT imaging biomarkers have shown predictive and prognostic value, but data are heterogeneous across studies. Post-therapy SPECT\u002FCT dosimetry is less studied, and studies integrating diagnostic PET biomarkers, post-therapy dosimetry, and clinical-biochemical markers in one multivariable model are lacking.\n\nHYPOTHESIS Baseline 68Ga-PSMA PET\u002FCT imaging biomarkers, post-therapy 177Lu-PSMA SPECT\u002FCT dosimetry parameters, and clinical and biochemical markers assessed before and during treatment, alone and in combination, predict response to RLT and progression-free survival in patients with mCRPC.\n\nOBJECTIVES\n\n1. To assess the predictive value of baseline 68Ga-PSMA PET\u002FCT imaging biomarkers for response to 177Lu-PSMA RLT.\n2. To assess the relationship between post-therapy 177Lu-PSMA SPECT\u002FCT dosimetry parameters and baseline 68Ga-PSMA PET\u002FCT biomarkers, and their predictive value for treatment response.\n3. To assess the predictive value of clinical, quality of life, biochemical, and molecular markers observed before and during treatment.\n4. To assess the applicability of treatment response criteria and their prognostic value for progression-free and overall survival.\n5. To develop a multivariable predictive model integrating imaging, dosimetric, clinical, and biochemical markers and to assess its accuracy in predicting treatment outcomes.\n\nDESIGN Single-center observational cohort study at the Department of Nuclear Medicine, Lithuanian University of Health Sciences Hospital Kaunas Clinics, with two data collection streams: a prospective stream (newly treated patients, with informed consent) and a retrospective stream (up to approximately 20 patients who started RLT before study start; waiver of informed consent granted). The same data are collected in both streams. Treatment is given according to the approved Summary of Product Characteristics (SmPC), independently of study participation. Planned total sample: 70 patients.\n\nTREATMENT (STANDARD CARE) \\[177Lu\\]Lu-PSMA-617 7400 MBq intravenously every 6 weeks (plus or minus 1 week), up to 6 cycles, with dose modification, delay, or discontinuation per SmPC. Androgen deprivation therapy with GnRH analogues is continued.\n\n68Ga-PSMA-11 PET\u002FCT Baseline PET\u002FCT before the first cycle and follow-up PET\u002FCT approximately 4 to 8 weeks after the last cycle. Images are analyzed according to PROMISE V2 (miTNM staging, miPSMA score). Quantitative parameters: SUVmax, SUVmean, PSMA-positive tumor volume (PSMA-TV), and number of lesions, recorded by region (local disease, regional lymph nodes, distant metastases) where technically feasible.\n\nPOST-THERAPY SPECT\u002FCT DOSIMETRY Quantitative three-timepoint SPECT\u002FCT after every cycle on a cadmium-zinc-telluride (CZT) SPECT\u002FCT camera, per EANM\u002FSNMMI and EANM Dosimetry Committee recommendations: 3 to 4 hours (biodistribution and extravasation check), 24 hours, and 120 hours post-infusion. Absorbed doses (Gy) per cycle are calculated for kidneys, salivary glands, bone marrow, and tumor lesions, plus other parameters available in the dosimetry software.\n\nLABORATORY AND CLINICAL DATA Blood tests (complete blood count, ALT, AST, albumin, total bilirubin, creatinine, creatinine clearance, alkaline phosphatase, LDH, PSA, CRP, ferritin; testosterone at baseline only) at baseline, 10 to 11 days before each subsequent cycle, 2 to 3 weeks after each cycle, 4 to 6 weeks after the last cycle, and every 4 to 6 months during follow-up. Clinical data include demographics, Gleason\u002FISUP grade, prior treatments, ECOG performance status, pain score (NRS 0 to 10), metastatic pattern, PSA doubling time, comorbidities, and subsequent treatments after RLT.\n\nADDITIONAL (NON-STANDARD) STUDY PROCEDURES\n\n1. Circulating tumor DNA (ctDNA) quantification: 10 ml blood drawn during the same venipuncture as routine blood tests, 2 to 3 weeks after each cycle.\n2. SF-36 health-related quality of life questionnaire (validated Lithuanian version) before cycle 1 and after cycles 2, 4, and 6 (or at treatment completion), completed during hospitalization.\n\nFOLLOW-UP Patients are followed within standard oncological follow-up every 4 to 6 months until study end. The last enrolled patient is followed for at least 6 months.\n\nSAMPLE SIZE Calculated with G\\*Power 3.1.9.7 (chi-square test of independence, df = 1), effect size w = 0.35 based on published PSA50 response differences of 32 to 39 percentage points between favorable and unfavorable baseline PSMA PET\u002FCT biomarker groups, alpha = 0.05, power = 0.80: minimum n = 65. With approximately 10% allowance for missing data, 70 patients are planned.\n\nSTATISTICAL ANALYSIS Normality is tested with the Kolmogorov-Smirnov test. PSA50 response rate is reported with 95% CI. Associations with PSA50 response are assessed by logistic regression and predictive accuracy by ROC analysis (AUC with 95% CI). Associations with PFS and OS are assessed by Cox proportional hazards regression (HR with 95% CI); PFS and OS are estimated by Kaplan-Meier with log-rank tests. Correlations between dosimetry and PET\u002FCT parameters are assessed by Pearson or Spearman coefficients. Agreement between response criteria is assessed by Cohen's kappa. Significant predictors enter multivariable models (logistic regression for PSA50, Cox regression for survival), with up to 3 independent variables per the EPV of 10 or more rule. SF-36 change from baseline and its relation to response are assessed; ctDNA analysis is exploratory. Two-sided p \\\u003C 0.05 is significant. Analyses are performed in SPSS.","Patients with metastatic castration-resistant prostate cancer treated with \\[177Lu\\]Lu-PSMA-617 (Pluvicto) radioligand therapy at the Department of Nuclear Medicine, Lithuanian University of Health Sciences Hospital Kaunas Clinics, Kaunas, Lithuania. The study includes two streams: a prospective stream of patients starting or continuing radioligand therapy after study start, who are invited to participate during a routine clinical visit, and a retrospective stream of up to approximately 20 patients whose radioligand therapy began at the same center before study start and whose already collected clinical, imaging, and dosimetric data are analyzed from medical records. Advertisements are not used.",[40,44,48,51],{"type":41,"name":42,"description":43,"armGroupLabels":34,"otherNames":34},"DRUG","[177Lu]Lu-PSMA-617 (Pluvicto, Novartis)","7400 MBq intravenously every 6 weeks (plus or minus 1 week), up to 6 cycles, given as routine care according to the approved Summary of Product Characteristics, independently of study participation.",{"type":45,"name":46,"description":47,"armGroupLabels":34,"otherNames":34},"DIAGNOSTIC_TEST","68Ga-PSMA-11 PET\u002FCT","Baseline scan before the first cycle and follow-up scan approximately 4 to 8 weeks after the last cycle, performed as routine care. Images are analyzed using a standardized assessment framework, and quantitative PET parameters are recorded.",{"type":45,"name":49,"description":50,"armGroupLabels":34,"otherNames":34},"Post-therapy 177Lu-PSMA SPECT\u002FCT dosimetry","Quantitative SPECT\u002FCT at 3 to 4 hours, 24 hours, and 120 hours after each cycle, performed as routine care. Absorbed doses are calculated for organs at risk and tumor lesions.",{"type":6,"name":52,"description":53,"armGroupLabels":34,"otherNames":34},"Circulating tumor DNA (ctDNA) quantification","Study-specific blood sample (10 ml) collected during the same venipuncture as routine blood tests, 2 to 3 weeks after each cycle.",[55],{"facility":56,"status":57,"city":58,"state":34,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Lithuanian University of Health Sciences Hospital Kaunas Clinics, Department of Nuclear Medicine","RECRUITING","Kaunas","50161","Lithuania","LT",{"type":63,"coordinates":64},"Point",[65,66],23.90909,54.90156,{"lat":66,"lon":65},[69],{"name":70,"role":71,"phone":72,"phoneExt":34,"email":73},"Grytė Galnaitienė, MD","CONTACT","+370 37 326586","gryte.galnaitiene@lsmu.lt",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Grytė Galnaitienė","Radiologist, PhD Candidate","100659386","predictive-factors-for-response-to-lutetium-177-psma-radioligand-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-100659386",false,"NCT07863986","Predictive Factors for Response to Lutetium-177 PSMA Radioligand Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer","Identification of Novel Predictive Factors and Their Significance for Improving Radioligand Therapy Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer","Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically confirmed prostate adenocarcinoma\n* Progressive, PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) for which \\[177Lu\\]Lu-PSMA-617 (Pluvicto) radioligand therapy has been given or is planned, according to the approved Summary of Product Characteristics (previous treatment with an androgen receptor pathway inhibitor and taxane-based chemotherapy)\n* PSMA positivity confirmed on diagnostic \\[68Ga\\]Ga-PSMA-11 PET\u002FCT before the start of treatment, defined as at least one tumor lesion with uptake higher than in normal liver\n* For the prospective part: signed informed consent. For the retrospective part: ethics committee waiver of the requirement to obtain informed consent\n\nExclusion Criteria:\n\n* Contraindications to \\[177Lu\\]Lu-PSMA-617 (Pluvicto) therapy according to the Summary of Product Characteristics\n* No PSMA-positive lesions on diagnostic PSMA PET\u002FCT\n* Diagnostic PSMA PET\u002FCT not performed with \\[68Ga\\]Ga-PSMA-11, or not available for quantitative analysis (original images not saved or not accessible)\n* Another active malignancy (except non-melanoma skin cancer or a clinically insignificant tumor) that could affect the assessment of survival\n* Refusal to participate in the study (for the prospective part: informed consent not signed)","MALE","18 Years",{"count":88,"type":89},70,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn which factors can predict how well lutetium-177 PSMA therapy works in people with metastatic castration-resistant prostate cancer (mCRPC). This therapy is a radioactive medicine (Pluvicto) given into a vein.\n\nThe main questions it aims to answer are:\n\n* Can scan results, radiation dose measurements, and blood test results predict which participants will have their prostate-specific antigen (PSA) level drop by half or more?\n* Can the same results predict how long participants live without their cancer getting worse?\n\nAll participants receive Pluvicto as part of their regular medical care. Taking part in the study does not change their treatment.\n\nParticipants will:\n\n* Receive up to 6 Pluvicto treatments, about every 6 weeks, as part of regular care\n* Have a PSMA PET\u002FCT scan (an imaging test that shows where the cancer is) before treatment and after the last treatment, as part of regular care\n* Have 3 SPECT\u002FCT scans after each treatment (at 3 to 4 hours, 24 hours, and 5 days) to measure how much radiation reached the tumors and organs, as part of regular care\n* Give 1 extra blood sample (10 ml) after each treatment to measure tumor DNA in the blood. It is taken from the same needle stick as routine blood tests.\n* Fill in a quality of life questionnaire (SF-36) before treatment and after every second treatment, during their hospital stay\n* Have check-ups every 4 to 6 months after treatment ends\n\nResearchers will also use existing medical records of people who started Pluvicto at the hospital before the study began.",[93,94,95,96],"Prostate Cancer","Prostatic Neoplasms","Prostatic Neoplasms, Castration-Resistant","Neoplasm Metastases","2026-10-06",{"date":99,"type":100},"2026-10-07","ACTUAL",{"date":102,"type":100},"2026-08-04",{"date":104,"type":89},"2031-08",{"name":5,"class":6},1]