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

2026년 9월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

관찰

등록 (추정된)

50

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 인도
      • Many Locations, 인도
        • Many locations

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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
의약품: 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.
다른 이름들:
  • 베이 1841788
  • 누베카

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of adverse events and serious adverse events
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in hematology laboratory parameters: hemoglobin
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Bayer

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 5일

기본 완료 (추정된)

2028년 10월 31일

연구 완료 (추정된)

2028년 10월 31일

연구 등록 날짜

최초 제출

2026년 8월 18일

QC 기준을 충족하는 최초 제출

2026년 9월 1일

처음 게시됨 (실제)

2026년 9월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 9일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 23276

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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