protocolSection identificationModule nctId: NCT06379217, orgStudyIdInfo id: CAAA617H12101, secondaryIdInfos id: 2023-505655-43, type: EUDRACT_NUMBER, briefTitle: NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-18, primaryCompletionDateStruct date: 2027-06-04, completionDateStruct date: 2027-06-04, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gonadotropin Releasing Hormone Receptor (GRPR)) between the start and after the completion of radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC)., conditionsModule conditions: Metastatic Neuroendocrine Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be assigned to a treatment arm based on their predominantly expressed target per PET images (based on central read):* \[177Lu\]Lu-PSMA-617 will be assigned to those with predominant PSMA expression* \[177Lu\]Lu-DOTA-TATE will be assigned to those with predominant SSTR2 expression* \[177Lu\]Lu-NeoB will be assigned to those with predominant GRPR expression, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: [68Ga]Ga-PSMA-11, interventions name: [68Ga]GA-DOTA-TATE, interventions name: [68Ga]Ga-NeoB, interventions name: [177Lu]Lu-PSMA-617, interventions name: [177Lu]Lu-DOTA-TATE, interventions name: [177Lu]Lu-NeoB, interventions name: L-Lysine HCl-L-Arginine HCl, 2.5 %,, interventions name: Gonadotropin-releasing hormone (GnRH) analogues, interventions name: GnRH antagonists, interventions name: Antiemetics & antinauseants, interventions name: Metoclopramide, outcomesModule primaryOutcomes measure: Number/extent of lesions with at least a moderate uptake of any of the Radioligand Imaging (RLI), primaryOutcomes measure: Percentage changes in qualitative PET parameters., secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Radiographic Progression-free Survival (rPFS), secondaryOutcomes measure: Proportion of participants with a decline in PSA level, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Therapy (RLT), secondaryOutcomes measure: Dose modifications for [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) for Radioligand Imaging (RLI), secondaryOutcomes measure: Blood radioactivity concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB), secondaryOutcomes measure: Blood mass concentration of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-NeoB), secondaryOutcomes measure: Observed maximum blood concentrations (Cmax) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Time of maximum blood concentration (Tmax) occurence of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Area under the blood concentration time curve (AUC) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Total systemic clerance (CL) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Terminal half-life (T^1/2) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Absorbed radiation doses of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, secondaryOutcomes measure: Time Activity Curves (TACs) of [177Lu]Lu-PSMA-617, [177Lu]Lu-DOTA-TATE and [177Lu]Lu-NeoB, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False