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A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer

15. juli 2026 opdateret af: Novartis Pharmaceuticals

Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Contemporary Patients With Metastatic Castration-Resistant Prostate Cancer in the PRECISION Data Platform

The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) 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.

Studieoversigt

Status

Rekruttering

Betingelser

Prostatiske neoplasmer, kastrationsresistente

Undersøgelsestype

Observationel

Tilmelding (Anslået)

17111

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Novartis Pharmaceuticals
Telefonnummer: +41613241111
E-mail: novartis.email@novartis.com

Undersøgelse Kontakt Backup

Navn: Novartis Pharmaceuticals

Studiesteder

Forenede Stater
- New Jersey
  - East Hanover, New Jersey, Forenede Stater, 07936
    - Rekruttering
    - Novartis

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult male patients with a confirmed mCRPC diagnosis in the US in the last 5 years who are included in the PRECISION data platform.

Beskrivelse

Inclusion criteria:

Diagnosis of mCRPC between 01 January 2021 and 31 December 2025.
Male sex at index, where index is the date of initial mCRPC diagnosis.
Age 18 years at index.

Exclusion criteria:

• None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
mCRPC Cohort Adult male patients with a recent diagnosis of mCRPC in PRECISION.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Number of Patients by Prior Therapies Tidsramme: Baseline		Baseline
Number of Patients by Number of Post-index Lines of Therapy (LOTs) Tidsramme: Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each LOT Tidsramme: Up to approximately 5 years		Up to approximately 5 years
Percentage of Patients Switching From One Type of Therapy to Another at Each LOT Tidsramme: Up to approximately 5 years		Up to approximately 5 years
Time to First-line (1L) Treatment Initiation (TTTI) Tidsramme: Up to approximately 5 years	Time from index date (mCRPC diagnosis) to the start of 1L treatment.	Up to approximately 5 years
Time to Next Therapy (TTNT) for Each LOT Tidsramme: Up to approximately 5 years	Time from the end of each LOT to initiation of the next LOT.	Up to approximately 5 years

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Alder Tidsramme: Baseline		Baseline
Number of Patients by Patient Characteristics Tidsramme: 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 Tidsramme: Up to approximately 5 years	PFS from index date: time from mCRPC diagnosis (index date) until progression or death from any cause.	Up to approximately 5 years
PFS From Each LOT Tidsramme: Up to approximately 5 years	PFS from each LOT, among those with that LOT: time from the date of initiation of the LOT until progression or death from any cause.	Up to approximately 5 years
Overall Survival (OS) From Index Date Tidsramme: Up to approximately 5 years	OS from index date: time from mCRPC diagnosis (index date) until death from any cause.	Up to approximately 5 years
OS From Each LOT Tidsramme: Up to approximately 5 years	OS from each LOT, among those with that LOT: time from the date of initiation of the LOT until death from any cause.	Up to approximately 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier