Идёт набор NCT07677267

A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

— Наблюдательное Prostatic Neoplasms, Castration-Resistant

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: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Prostatic Neoplasms, Castration-Resistant. Базовые параметры: 18 лет — 115 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: США
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

Real-World Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

Обзор

The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.

Первичные конечные точки

Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date [Срок оценки: Baseline]
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) [Срок оценки: Baseline]
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans [Срок оценки: Baseline up to approximately 5 years]
Number of Patients by Timing of PSMA Scans [Срок оценки: Baseline up to approximately 5 years]
Number of Patients by Number of Post-index LOTs [Срок оценки: Up to approximately 5 years]
Number of Patients by Type of Therapy at Each Post-index LOT [Срок оценки: Up to approximately 5 years]
Time From Index Date to Next Therapy Initiation [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (8)

Number of Patients by Patient Characteristics [Срок оценки: Baseline]
Age [Срок оценки: Baseline]
Progression-free Survival (PFS) From Index Date [Срок оценки: Up to approximately 5 years]
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy [Срок оценки: Up to approximately 5 years]
Overall Survival (OS) From Index Date [Срок оценки: Up to approximately 5 years]
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy [Срок оценки: Up to approximately 5 years]
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level [Срок оценки: Up to approximately 5 years]
Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Age ≥18 years at index.