A Registry of Participants With Prostate Cancer in Asia
2020년 9월 21일 업데이트: Janssen Research & Development, LLC
A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia
The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.
연구 개요
상세 설명
This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), longitudinal, observational registry (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions [as in an interventional study])of PC participants.
The following 3 participant cohorts will be enrolled: high-risk localized PC, non-metastatic biochemically recurrent PC, and metastatic PC.
This is an observational study and treatment decisions and clinical management of participants will follow routine clinical practice.
Medical care given to participants will not be influenced by participation in the study.
Enrolled participants will be prospectively followed throughout their course of treatment, during which data on PC treatment, clinical progression, and outcomes (including death) will be collected.
At the end of registry medical resource utilization (MRU) will also be collected.
The maximum observational period will be 5 years.
Safety will be monitored throughout the study for participants being treated with JNJ products.
연구 유형
관찰
등록 (실제)
3644
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Kaohsiung, 대만
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Tainan, 대만
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Taipei, 대만
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Seoul, 대한민국
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Kuala Lumpur, 말레이시아
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Kuala Lumpur N/a, 말레이시아
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Kuching, 말레이시아
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Pulau Pinang, 말레이시아
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Singapore, 싱가포르
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Bangalore, 인도
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Delhi, 인도
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Mumbai, 인도
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New Delhi, 인도
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Chiba, 일본
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Hirosaki, 일본
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Ikoma, 일본
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Kobe, 일본
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Koshigaya, 일본
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Matsuyama, 일본
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Osaka-Sayama, 일본
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Suita, 일본
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Beijing, 중국
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Guangzhou, 중국
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Hangzhou, 중국
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Shanghai, 중국
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Shenyang, 중국
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Sichuan, 중국
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Su Zhou, 중국
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Wuhan, 중국
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Bangkok, 태국
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Chiang Mai, 태국
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Songkla, 태국
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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
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
남성
샘플링 방법
비확률 샘플
연구 인구
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
설명
Inclusion Criteria:
- Male aged 21 years or older
- Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic, biochemically recurrent PC; Metastatic PC
- Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable representative
- Agree to be followed-up for PC per routine clinical care
Exclusion Criteria:
- No specific exclusion criteria's were defined
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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High-risk localized Prostate Cancer (PC)
No intervention will be administered in this study.
Participants with High-risk localized PC will be enrolled.
High-risk localized PC involves clinical T stage greater than or equal to (>=) cT3a and one of the following high risk features: Gleason score 8-10 or prostate specific antigen (PSA) level above 20 nanogram per milliliter (ng/mL).
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This is an observational study.
No study medication is provided will be provided as part of participation.
Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry.
All treatment decisions will be made at the discretion of the investigator or treating physician.
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Non-metastatic Biochemically Recurrent PC
No intervention will be administered in this study.
Participants with Non-metastatic biochemically recurrent PC will be enrolled.
A non-metastatic biochemically recurrent PC involves a confirmed PSA value of >0.2 ng/mL following prostatectomy (European Association of Urology (EAU) guidelines), a PSA value of 2 ng/mL or more above the nadir following radiation therapy (American Society for Radiation Oncology (ASTRO) guidelines).
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This is an observational study.
No study medication is provided will be provided as part of participation.
Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry.
All treatment decisions will be made at the discretion of the investigator or treating physician.
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Metastatic PC
No intervention will be administered in this study.
Participants with Metastatic PC will be enrolled.
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This is an observational study.
No study medication is provided will be provided as part of participation.
Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry.
All treatment decisions will be made at the discretion of the investigator or treating physician.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival (OS)
기간: up to 5 years
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Overall survival is defined as the time from enrollment to date of death due to any cause.
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up to 5 years
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Prostate Cancer (PC)-related Mortality (PM)
기간: up to 5 years
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PC-related mortality is the death due to prostate cancer.
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up to 5 years
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Metastasis-free survival (MFS)
기간: up to 5 years
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MFS is defined as the time from enrollment to the date of the first occurrence of radiographic bone or soft tissue distant metastasis, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
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up to 5 years
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Progression-free Survival (PFS)
기간: up to 5 years
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Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.
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up to 5 years
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Time to Prostate-specific Antigen (PSA) Progression (TTPP)
기간: up to 5 years
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TTPP is defined as time from enrollment to the date of PSA progression.
In participants who has PSA level decreased, PSA progression is defined as 25 percent (%) increase (greater than or equal to [>=] 25%) from nadir (lowest value including baseline) and an increase in the absolute value of at least 2 nanogram per milliliter (ng/mL (>=2ng/mL) and is confirmed by a subsequent measurement at least 3 weeks (>=21 days; PCWG2) after the increase.
In participants in whom the PSA level had not decreased, PSA progression is defined as 25% increase (>=25%) from baseline and an increase in the absolute value of at least 2ng/mL (>=2ng/mL) after 12 weeks.
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up to 5 years
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European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
기간: up to 5 years
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The EQ-5D-5L is the new 5-level version of EQ-5D.
It describes health-related quality of life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Each item of the EQ-5D within these dimensions has 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems).
Data captured by EQ-5D-5L relates to the patient's status at the time of completion, and takes approximately 5 minutes to complete.
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up to 5 years
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Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
기간: up to 5 years
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The FACT-P consists of the FACT-General (FACT-G) and a PC-specific subscale.
The FACT-G contains a 27-item questionnaire and is composed of 4 dimensions of HRQoL: physical well-being, social/family well-being, emotional well-being, and functional well-being.
The PC-specific subscale is composed of 12 items, which span the dimensions of sexual function, bowel/bladder function, and pain.
The FACT-P questionnaire has a 7 day recall, and takes approximately 15 minutes to complete.
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up to 5 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Uemura H, Ye D, Kanesvaran R, Chiong E, Lojanapiwat B, Pu YS, Rawal SK, Abdul Razack AH, Zeng H, Chung BH, Md Yusoff NA, Ohyama C, Kim CS, Leewansangtong S, Tsai YS, Liu Y, Liu W, van Kooten Losio M, Asinas-Tan M. United in Fight against prOstate cancer (UFO) registry: first results from a large, multi-centre, prospective, longitudinal cohort study of advanced prostate cancer in Asia. BJU Int. 2020 Apr;125(4):541-552. doi: 10.1111/bju.14980. Epub 2020 Jan 30.
- Liu Y, Uemura H, Ye D, Lee JY, Chiong E, Pu YS, Razack AHA, Pripatnanont C, Rawal S, Low GKM, Qiu H, Chow WH, Van Kooten Losio M. Prostate cancer in Asia: design of a patient registry to inform real-world treatments, outcomes, and quality of life. Prostate Int. 2019 Sep;7(3):108-113. doi: 10.1016/j.prnil.2018.12.001. Epub 2018 Dec 24.
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 (실제)
2015년 9월 9일
기본 완료 (실제)
2020년 9월 1일
연구 완료 (실제)
2020년 9월 1일
연구 등록 날짜
최초 제출
2015년 9월 9일
QC 기준을 충족하는 최초 제출
2015년 9월 9일
처음 게시됨 (추정)
2015년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 9월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 9월 21일
마지막으로 확인됨
2020년 9월 1일
추가 정보
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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