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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

15 de julho de 2026 atualizado por: Novartis Pharmaceuticals

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Neoplasias Prostáticas Resistentes à Castração

Tipo de estudo

Observacional

Inscrição (Estimado)

1067

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Novartis Pharmaceuticals
Número de telefone: +41613241111
E-mail: novartis.email@novartis.com

Estude backup de contato

Nome: Novartis Pharmaceuticals

Locais de estudo

Estados Unidos
- New Jersey
  - East Hanover, New Jersey, Estados Unidos, 07936
    - Recrutamento
    - Novartis

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.

Descrição

Inclusion criteria:

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.

Exclusion criteria:

• None.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
Overall mCRPC Cohort Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION.
mCRPC Progression Subgroup A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.
≥1 Subsequent Systemic Therapy Subgroup A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date Prazo: Baseline	The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Baseline
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) Prazo: Baseline	Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.	Baseline
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans Prazo: Baseline up to approximately 5 years		Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans Prazo: Baseline up to approximately 5 years	Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Baseline up to approximately 5 years
Number of Patients by Number of Post-index LOTs Prazo: Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT Prazo: Up to approximately 5 years		Up to approximately 5 years
Time From Index Date to Next Therapy Initiation Prazo: Up to approximately 5 years	The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Up to approximately 5 years

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Era Prazo: Linha de base		Linha de base
Number of Patients by Patient Characteristics Prazo: Baseline	Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level.	Baseline
Progression-free Survival (PFS) From Index Date Prazo: Up to approximately 5 years	Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Up to approximately 5 years
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy Prazo: Up to approximately 5 years	Time from the initiation of first post-index therapy until progression or death from any cause.	Up to approximately 5 years
Overall Survival (OS) From Index Date Prazo: Up to approximately 5 years	Time from the applicable index date until death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Up to approximately 5 years
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy Prazo: Up to approximately 5 years	Time from initiation of first post-index therapy until death from any cause.	Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level Prazo: Up to approximately 5 years	Reduction in PSA level categorized as follows: ≥50% (PSA50) reduction in PSA level ≥80% (PSA80) reduction in PSA level ≥90% (PSA90) reduction in PSA level	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 Prazo: Up to approximately 5 years		Up to approximately 5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novartis Pharmaceuticals

Investigadores

Diretor de estudo: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

30 de junho de 2026

Conclusão Primária (Estimado)

30 de novembro de 2026

Conclusão do estudo (Estimado)

30 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

24 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ