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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Tumeurs prostatiques, résistantes à la castration

Type d'étude

Observationnel

Inscription (Estimé)

1067

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Novartis Pharmaceuticals
Numéro de téléphone: +41613241111
E-mail: novartis.email@novartis.com

Sauvegarde des contacts de l'étude

Nom: Novartis Pharmaceuticals

Lieux d'étude

États-Unis
- New Jersey
  - East Hanover, New Jersey, États-Unis, 07936
    - Recrutement
    - Novartis

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date Délai: 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) Délai: 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 Délai: Baseline up to approximately 5 years		Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans Délai: 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 Délai: Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT Délai: Up to approximately 5 years		Up to approximately 5 years
Time From Index Date to Next Therapy Initiation Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Âge Délai: Ligne de base		Ligne de base
Number of Patients by Patient Characteristics Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: Up to approximately 5 years		Up to approximately 5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis Pharmaceuticals

Les enquêteurs

Directeur d'études: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 juin 2026

Achèvement primaire (Estimé)

30 novembre 2026

Achèvement de l'étude (Estimé)

30 novembre 2026

Dates d'inscription aux études

Première soumission

24 juin 2026

Première soumission répondant aux critères de contrôle qualité