Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT06720532
Status:
RECRUITING
Last Update Posted:
2024-12-06
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and urine samples are collected from the participants.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2031-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'chronic kidney disease frequency', 'timeFrame': '2 years', 'description': 'The primary objective is to determine the long term frequency of chronic kidney disease as an expression of radiation nephropathy in patients treated with 177Lu-PSMA RLT, measured by the absolute decline in eGFR.'}], 'secondaryOutcomes': [{'measure': 'Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy', 'timeFrame': '5 years', 'description': 'Determination of the incidence of chronic kidney disease in long-term survivors following 177Lu-PSMA radioligand therapy (RLT), measured by the absolute decline in eGFR.'}, {'measure': 'Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD).', 'timeFrame': '2 years', 'description': 'Detection of clinical risk factors that promote the development of chronic kidney disease (CKD).'}, {'measure': 'Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD.', 'timeFrame': '2 years', 'description': 'Identification of renal biomarkers for the early detection of individuals at high risk of developing chronic kidney disease (CKD). Correlation of these biomarkers with the severity and timing of CKD onset. Measurement of established markers of glomerular injury, tubular damage, endothelial dysfunction, or functional impairment using ELISA.'}, {'measure': 'Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics.', 'timeFrame': '2 years', 'description': 'Deciphering potential pathomechanisms of renal damage using established serum biomarkers and urine proteomics via targeted and untargeted analyses.'}, {'measure': 'Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs).', 'timeFrame': '2 years', 'description': 'Measurement of quality of life, psychological distress, fear of progression, frailty, pain, decision regret, and treatment expectations using questionnaires.'}, {'measure': 'Longitudinal evaluation of potential radiation nephropathy.', 'timeFrame': '2 years', 'description': 'Regular assessments of kidney function will be conducted over a period of 2 years. This will allow for the identification of the onset of kidney function impairments.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mCRPC', '177Lutetium', '177Lu-PSMA', 'radioligand therapy'], 'conditions': ['Kidney Disease', 'Radiation Nephropathy', 'Metastatic Castrate Resistant Prostate Cancer (mCRPC)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the impact of 177Lutetium-Prostate Specific Membrane Antigen (PSMA) Radioligand Therapy (177Lu-PSMA-RLT) on kidney function over time. The main question it aims to answer is:\n\nWhat is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months?\n\nPatients treated with 177Lu-PSMA-RLT will have their kidney function monitored before, during, and after therapy using routine markers like creatinine and cystatin C. Additional biomarkers and urine proteomics will be collected to identify early detection markers and risk factors for chronic kidney disease (CKD). Follow-up examinations will be conducted at regular intervals up to 5 years. The study also aims to correlate clinical risk factors and patient-reported outcomes with kidney insufficiency to assess the impact of therapy and identify vulnerable patient groups.', 'detailedDescription': 'Patients with mCRPC treated at Klinikum rechts der Isar who are newly receiving therapy with 177Lu-PSMA-RLT will be included. To ensure data quality, standard operating procedures (SOPs) will be implemented for both technical measurements and data collection. Data entered into the registry will undergo double data verification against predefined rules for range and consistency with other data fields. This ensures the accuracy and reliability of the collected data. A detailed data dictionary will be maintained, describing each variable used in the registry, including its source, coding information (e.g., TNM staging system), and normal ranges if relevant. Patient reported outcomes (PROM) of cancer related symptoms and quality of life will be collected using standardized questionnaires.\n\nBased on the power calculation, a total of 100 patients will be included in the study. These patients will be followed up for a period of up to 5 years to ensure comprehensive data collection and analysis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All mCRPC patients starting with 177Lu-PSMA RLT at the Klinikum rechts der Isar', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).\n\nExclusion Criteria:\n\n* Missing or incomplete informed consent.\n* age below 18 years'}, 'identificationModule': {'nctId': 'NCT06720532', 'acronym': 'KiRi', 'briefTitle': 'Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-Trial', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': '177Lu-PSMA-KiRi-trial', 'orgStudyIdInfo': {'id': '2023-402-S-KK'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mCRPC Patients with 177Lutetium-PSMA RLT', 'description': 'Patients diagnosed with metastatic castration-resistant prostate carcinoma (mCRPC) undergoing initial treatment with 177Lutetium-PSMA radioligand therapy at the Klinikum rechts der Isar.', 'interventionNames': ['Diagnostic Test: characterization of renal function.', 'Diagnostic Test: Handgrip strength test', 'Diagnostic Test: Questionaires']}], 'interventions': [{'name': 'characterization of renal function.', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood and urine sample collection', 'armGroupLabels': ['mCRPC Patients with 177Lutetium-PSMA RLT']}, {'name': 'Handgrip strength test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue.', 'armGroupLabels': ['mCRPC Patients with 177Lutetium-PSMA RLT']}, {'name': 'Questionaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'The questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.', 'armGroupLabels': ['mCRPC Patients with 177Lutetium-PSMA RLT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hannah/Christoph Schäfer/Schmaderer', 'role': 'CONTACT', 'email': 'hannah.schaefer@mri.tum.de, christoph.schmaderer@mri.tum.de', 'phone': '+498941408383, +498941405053'}], 'facility': 'Klinikum rechts der Isar, München, Bavaria 81675', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Hannah Schäfer/ Christoph Schmaderer', 'role': 'CONTACT', 'email': 'hannah.schaefer@mri.tum.de', 'phone': '+49 - 89 4140 8383', 'phoneExt': '+498941405053'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannah Schaefer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hannah Schaefer', 'investigatorAffiliation': 'Technical University of Munich'}}}}