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Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer (prostate)

22. juli 2026 opdateret af: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Objectives of Study： Primary Objective: To observe and evaluate the safety of abiraterone acetate tablets (II) and conventional abiraterone tablets in patients with metastatic prostate cancer under real-world conditions, including the types, incidence, and severity of treatment-related adverse events. Secondary Objectives: 1) To observe and evaluate the efficacy of abiraterone acetate tablets (II) and conventional abiraterone tablets in patients with metastatic prostate cancer under real-world conditions, including PSA response, radiographic progression-free survival (rPFS), overall survival (OS), etc.; 2) To observe the adherence of metastatic prostate cancer patients to abiraterone acetate tablets (II) and conventional abiraterone tablets under real-world conditions, including dosage and duration of treatment (DOT); 3) To observe the impact of baseline characteristics of different prostate cancer patients on treatment outcomes, such as ECOG PS score, PSA value, Gleason score, tumor burden, quality of life, etc.; 4) To preliminarily evaluate and compare the pharmacoeconomics of abiraterone acetate tablets (II) and conventional abiraterone tablets in treating Chinese patients with metastatic prostate cancer.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

3000

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Nanjing, Kina
        • Nanjing Drum Tower Hospital

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

  • Diagnosed with metastatic prostate cancer
  • Researchers assess eligibility to use abiraterone acetate tablets (II) for treatment, or previous use, or ongoing treatment with abiraterone acetate tablets (II)

Beskrivelse

Inclusion Criteria:

  • Queue One & Queue Two: Age ≥ 18 years
  • Queue One & Queue Two: Diagnosed with metastatic prostate cancer
  • Queue One: Researchers assess eligibility to use abiraterone acetate tablets (II) for treatment, or previous use, or ongoing treatment with abiraterone acetate tablets (II)
  • Queue One: Sign informed consent and voluntarily join this study
  • Queue 1: Male patients whose partners are women of childbearing potential should undergo surgical sterilization or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
  • Queue Two: Previously used ordinary Abiraterone Acetate tablets continuously for more than 3 cycles
  • Queue 2: At least one efficacy assessment after medication

Exclusion Criteria:

  • Queue One: Patients with severe liver dysfunction (Child-Pugh Class C)
  • Queue One: Currently participating in other clinical studies related to abiraterone acetate tablets (II)
  • Queue One & Queue Two: Researchers determine other situations that are not suitable for inclusion in the study
  • Queue Two: Patients with severely missing medical record data

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Queue One
  1. Age ≥ 18 years old;
  2. Diagnosed with metastatic prostate cancer;
  3. Researchers assess that the patient can use abiraterone acetate tablets (II) for treatment, or has previously received, or is currently receiving abiraterone acetate tablets (II) treatment;
  4. Sign the informed consent and voluntarily join this study;
  5. Male patients with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
Medicin: abiraterone acetate tablets (II)
  1. Age ≥ 18 years old;
  2. Diagnosed with metastatic prostate cancer;
  3. Researchers assess that the patient can use abiraterone acetate tablets (II) for treatment, or has previously received, or is currently receiving abiraterone acetate tablets (II) treatment;
  4. Sign the informed consent and voluntarily join this study;
  5. Male patients with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
Queue Two
  1. Age ≥18 years old;
  2. Diagnosed with metastatic prostate cancer;
  3. Previously used abiraterone acetate tablets continuously for more than 3 cycles;
  4. At least one efficacy evaluation after medication.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SAE
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Serious adverse event
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
TEAE
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Adverse events caused by treatment
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DOT
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Compliance indicators: duration of medication (DOT);
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
rPFS
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Relapse-Free Survival
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
OS
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
overall survival
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
PSA
Tidsramme: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
PSA response rate
1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

Samarbejdspartnere og efterforskere

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Samarbejdspartnere

Jiangsu Hengrui Pharmaceutical Co., Ltd.
Northern Jiangsu People's Hospital

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)

8. januar 2025

Primær færdiggørelse (Anslået)

21. december 2027

Studieafslutning (Anslået)

21. december 2027

Datoer for studieregistrering

Først indsendt

10. april 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IUNU-PC-127
  • Jiangsu Hengrui (Andet bevillings-/finansieringsnummer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med abiraterone acetate tablets (II)

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