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Идёт набор NCT06720532

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

— Наблюдательное Kidney Disease Radiation Nephropathy Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: characterization of renal function., Handgrip strength test, Questionaires.
Кому может быть актуально
Состояния в реестре: Kidney Disease, Radiation Nephropathy, Metastatic Castrate Resistant Prostate Cancer (mCRPC). Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

177Lu-PSMA-KiRi-trial

Обзор

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: What is the absolute decline in estimated glomerular filtration rate (eGFR) in patients undergoing 177Lu-PSMA-RLT after 12 and 24 months? Patients 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.

Подробное описание

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.

Based 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.

Вмешательства

  • Диагностический тест characterization of renal function.
    Blood and urine sample collection
  • Диагностический тест Handgrip strength test
    Assess the peak isometric strength of the hand and forearm muscles, as well as their susceptibility to fatigue.
  • Диагностический тест Questionaires
    The questionnaires evaluate quality of life, psychological distress, fear of progression, frailty, pain, decision regret and treatment expectations.

Первичные конечные точки

  • chronic kidney disease frequency [Срок оценки: 2 years]
Вторичные конечные точки (6)
  • Incidence of chronic kidney disease in patients with long-term survival following 177Lu-PSMA radioligand therapy [Срок оценки: 5 years]
  • Identification of Clinical Risk Factors for the Development of Chronic Kidney Disease (CKD). [Срок оценки: 2 years]
  • Identification and Correlation of Renal Biomarkers for Early Detection of High-Risk Individuals for CKD. [Срок оценки: 2 years]
  • Elucidating Potential Pathomechanisms of Renal Damage through established Serum Biomarkers and Urine Proteomics. [Срок оценки: 2 years]
  • Effects of 177Lu-PSMA Radioligand Therapy and its Side Effects on Patient-Reported Outcomes (PROMs). [Срок оценки: 2 years]
  • Longitudinal evaluation of potential radiation nephropathy. [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Patients with mCRPC starting 177Lu-PSMA RLT at the Klinikum rechts der Isar at the time of therapy initiation (1st cycle).

Критерии исключения

  • Missing or incomplete informed consent.
  • age below 18 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Klinikum rechts der Isar, München, Bavaria 81675 — Munich

Идентификаторы

NCT: NCT06720532 · 2023-402-S-KK

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗