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A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India (PACE mHSPC)

9. september 2026 oppdatert av: Bayer

An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

This study will follow patients with metastatic hormone-sensitive prostate cancer in India who receive darolutamide plus androgen deprivation therapy as part of routine medical care. The study aims to describe the real-world safety profile of darolutamide plus androgen deprivation therapy over up to 1 year of follow-up, including adverse events, serious adverse events, adverse events categorized as special topics, treatment changes, and changes in laboratory values, vital signs, and Eastern Cooperative Oncology Group performance status.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

50

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • India
      • Many Locations, India
        • Many locations

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Male patients with a diagnosis of metastatic hormone sensitive prostate cancer (mHSPC) will be enrolled after the decision for treatment with darolutamide has been made by the physician.

Beskrivelse

Inclusion Criteria:

  • Men over the age of 18 years
  • Histologically or cytologically confirmed adenocarcinoma of prostate
  • Metastatic disease (metastatic hormone sensitive prostate cancer) documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigators
  • The decision to initiate treatment with darolutamide plus androgen deprivation therapy (ADT) was made as per the investigator's routine treatment practice
  • Written informed consent

Exclusion Criteria:

  • Participation in an interventional clinical trial program with interventions outside of routine clinical practice
  • Any condition that, in investigator's opinion, precludes reliable safety follow-up.
  • Concomitant use or planned to start the use of docetaxel/any other androgen receptor inhibitors/radiation therapy/chemotherapy or immunotherapy
  • Known hypersensitivity to the study drug or any of its ingredients
  • Metastatic castration resistant prostate cancer (mCRPC) disease

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Single-arm post marketing surveillance cohort
Patients with metastatic hormone-sensitive prostate cancer in India who are treated with darolutamide in combination with androgen deprivation therapy as part of routine clinical practice
Legemiddel: Darolutamide plus androgen deprivation therapy
Darolutamide 300 mg film-coated tablets in combination with androgen deprivation therapy (ADT). The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
Andre navn:
  • BAY 1841788
  • NUBEQA

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and severity of adverse events and serious adverse events
Tidsramme: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Occurrence of adverse events, including AE/SAE terms, dates, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, outcome, actions taken, and seriousness criteria
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Incidence of discontinuations and dose modifications of study drug due to adverse events
Tidsramme: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Adverse event-related drug discontinuations/modifications, including adverse events leading to dose modification/discontinuation, dates, and reason
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in hematology laboratory parameters: hemoglobin
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: hematocrit
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: erythrocyte count
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: leukocyte count
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: lymphocytes
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: monocytes
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: eosinophils
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: neutrophils
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: basophils
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular volume
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: mean corpuscular hemoglobin concentration
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in hematology laboratory parameters: thrombocytes
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: albumin
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alanine aminotransferase
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: aspartate aminotransferase
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: alkaline phosphatase
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: gamma-glutamyl transferase
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bilirubin total and direct
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: calcium
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: blood urea nitrogen
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: creatinine
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: serum glucose
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total protein
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: lactate dehydrogenase
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: sodium
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: potassium
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: chloride
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: bicarbonate
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: testosterone
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: total prostate-specific antigen (PSA)
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: prothrombin time
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in clinical chemistry laboratory parameters: international normalized ratio (INR)
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: specific gravity
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: pH, by dipstick
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: glucose, by dipstick
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: protein, by dipstick
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: blood, by dipstick
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: ketones, by dipstick
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in routine urinalysis parameters: microscopic examination
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Microscopic examination, if blood or protein urinalysis by dipstick is abnormal
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Results of other safety laboratory tests performed as deemed necessary by the investigator
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Changes in Eastern Cooperative Oncology Group performance status and vitals
Tidsramme: Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Eastern Cooperative Oncology Group performance status on a scale from 0 to 5
Baseline, follow-up visits, and end of observation visit, over a total duration of approximately 12 months
Incidence and severity of adverse events categorized as special topics
Tidsramme: From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months

Occurrence of adverse events categorized as special topics, including category, severity as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, causality, actions taken, hospitalization, and discontinuation. Special topics are defined as:

  • hypertension
  • vasodilatation and flushing
  • diabetes mellitus and hyperglycemia
  • cardiac arrhythmias
  • fatigue
  • rash
  • bone fracture, excluding pathological fractures
  • coronary artery disorders
  • decreased weight
  • mental-impairment disorder
  • falls, including accident
  • heart failure
  • depressed-mood disorder
  • seizures
  • gynecomastia
  • cerebral ischemia.
From first application of darolutamide after enrollment through the observation period, including up to 30 days after the last dose of darolutamide within the study period, for a total duration of approximately 13 months
Drug administration status
Tidsramme: From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months
Drug exposure and modifications, including start/stop dates, dose, interruptions, reductions, discontinuation reasons, and cumulative dose
From baseline/first dose through the treatment and observation period, over a total duration of approximately 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bayer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

5. oktober 2026

Primær fullføring (Antatt)

31. oktober 2028

Studiet fullført (Antatt)

31. oktober 2028

Datoer for studieregistrering

Først innsendt

18. august 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

8. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 23276

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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