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A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)

18. August 2026 aktualisiert von: Pfizer

Real-World Outcomes Among Patients Receiving Enzalutamide Plus ADT or Darolutamide Plus ADT in Metastatic Castration Sensitive Prostate Cancer (mCSPC)

The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). ADT is a hormone therapy used to stop testosterone from being released or to prevent it from acting on prostate cells. The study includes men with metastatic castration-sensitive prostate cancer (mCSPC). This is a cancer that has spread outside the prostate to other parts of the body, but can still be successfully managed by lowering male hormones like testosterone. The study uses data from the Flatiron's Prostate Cancer Panoramic Database. This data base contains information on prostate cancer patients such as their clinical characteristics, lab, vitals, treatments and outcomes.

This study is seeking participants included in the Flatiron Prostate Cancer Panoramic dataset who:

  • Have a diagnosis of prostate cancer (PC) that has spread to other parts of the body
  • With at least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011
  • Has proof of treatment with enzalutamide or darolutamide in combination with ADT as a first line treatment
  • The treatment with enzalutamide or darolutamide in combination with ADT is no more than 30 days prior to or 6 months after the mCSPC diagnosis date

All participants in this study received at least 1 dose of enzalutamide or darolutamide in combination with ADT. The experiences of the participants receiving the enzalutamide or darolutamide will be looked at.

Participants will take part in this study for at least 6 months. During this time, they will have at least 2 documented clinic visits from 01 January 2011 to 31 March 2026. These visits will be updated if newer information becomes available at the time of the analysis.

Studienübersicht

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

4700

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

This is a retrospective cohort study of patients with mCSPC initiating first-line (1L) enzalutamide plus ADT or darolutamide plus ADT without other life-prolonging therapies in the US identified from the Flatiron's Prostate Cancer Panoramic Database. The dataset will include all protocol-required, retrospective patient-level data available for eligible patients from 01 January 2011, through the expected data cutoff date of 31 March 2026, which may be updated if newer data cuts become available at the time of the analysis.

Beschreibung

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients included in the Flatiron Prostate Cancer Panoramic dataset:

    1. Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x)
    2. At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011
    3. Has evidence of diagnosis of PC with an initial or metastatic diagnosis date.
  2. Evidence of mCSPC diagnosis date, as defined below:

    a. The mCSPC diagnosis date is determined using information on the date of metastatic diagnosis and the CSPC status. The data of metastatic diagnosis is the earliest date of the first confirmation of metastatic prostate cancer using the following hierarchy, where available: 1) Biopsy specimen collection date from the pathology report; 2) Physician reported date of biopsy; 3) Date of the radiology scan that indicated metastatic disease, if it was later confirmed by the physician; 4) Physician reported date of metastatic diagnosis. CSPC status is determined based on the following hierarchical evidence sources: 1) metastatic diagnosis date (if metastatic at initial diagnosis); 2) Explicit clinician documentation of CSPC; 3) Earliest ADT start date; 4) Clinician documented response or PSA decline while on ADT

  3. Has evidence of treatment with enzalutamide or darolutamide in combination with ADT in the 1L mCSPC setting , on or after 01 August 2022.

    Note: The index date is the start of the ARPI in combination with ADT (i.e., the first episode of ARPI treatment, which can occur up to 90 days after initiation of 1L therapy if ADT is initiated before the ARPI).

  4. Index date is no more than 30 days prior to or 6 months after the mCSPC diagnosis date

Patients meeting any of the following criteria will not be included in the study:

  1. Birth sex reported as female or unknown
  2. Age <18 years at index date
  3. Evidence of receiving a clinical study drug on or prior to index date
  4. Diagnosed with neuroendocrine and/or small cell PC on or prior to index
  5. Diagnosed with additional malignancies, excluding nonmelanoma skin cancer, at any time prior to index date
  6. Index date <6 months prior to data cutoff date
  7. Received multiple ARPIs or ARPI in combination with any drug other than ADT or first-generation anti-androgen treatments prior to and up to 28 days after index date
  8. Evidence of ADT or first-generation anti-androgen treatment between 1 year and 91 days prior to index date
  9. Evidence of an orchiectomy occurring more than 90 days prior to index date
  10. Evidence of CRPC any time prior or up to 90 days after the index date
  11. Evidence of treatments for mCRPC on or prior to index date
  12. Has a Line 0 as defined by Flatiron line of therapy (LOT) business rules, indicating potentially missing treatment data at the start of mCSPC setting
  13. Received docetaxel prior to and up to 120 days after index date

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
darolutamide plus androgen deprivation therapy
As provided in real world setting
enzalutamide plus androgen deprivation therapy
As provided in real world setting

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Median Real-world time to next treatment (rwTTNT)
Zeitfenster: time from index date to the start of the next treatment course (August 1, 2022- March 31, 2026)
time from index date to the start of the next treatment course (August 1, 2022- March 31, 2026)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Studienleiter: Pfizer CT.gov Call Center, Pfizer

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

15. November 2026

Studienabschluss (Geschätzt)

15. November 2026

Studienanmeldedaten

Zuerst eingereicht

18. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

21. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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