A Registry of Participants With Prostate Cancer in Asia
2020年9月21日 更新者：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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
3644
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Beijing、中国
-
Guangzhou、中国
-
Hangzhou、中国
-
Shanghai、中国
-
Shenyang、中国
-
Sichuan、中国
-
Su Zhou、中国
-
Wuhan、中国
-
-
-
-
-
Bangalore、印度
-
Delhi、印度
-
Mumbai、印度
-
New Delhi、印度
-
-
-
-
-
Kaohsiung、台湾
-
Tainan、台湾
-
Taipei、台湾
-
-
-
-
-
Seoul、大韩民国
-
-
-
-
-
Singapore、新加坡
-
-
-
-
-
Chiba、日本
-
Hirosaki、日本
-
Ikoma、日本
-
Kobe、日本
-
Koshigaya、日本
-
Matsuyama、日本
-
Osaka-Sayama、日本
-
Suita、日本
-
-
-
-
-
Bangkok、泰国
-
Chiang Mai、泰国
-
Songkla、泰国
-
-
-
-
-
Kuala Lumpur、马来西亚
-
Kuala Lumpur N/a、马来西亚
-
Kuching、马来西亚
-
Pulau Pinang、马来西亚
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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).
|
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.
|
|
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).
|
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.
|
|
Metastatic PC
No intervention will be administered in this study.
Participants with Metastatic PC will be enrolled.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：up to 5 years
|
Overall survival is defined as the time from enrollment to date of death due to any cause.
|
up to 5 years
|
|
Prostate Cancer (PC)-related Mortality (PM)
大体时间：up to 5 years
|
PC-related mortality is the death due to prostate cancer.
|
up to 5 years
|
|
Metastasis-free survival (MFS)
大体时间：up to 5 years
|
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.
|
up to 5 years
|
|
Progression-free Survival (PFS)
大体时间：up to 5 years
|
Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.
|
up to 5 years
|
|
Time to Prostate-specific Antigen (PSA) Progression (TTPP)
大体时间：up to 5 years
|
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.
|
up to 5 years
|
|
European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
大体时间：up to 5 years
|
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.
|
up to 5 years
|
|
Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
大体时间：up to 5 years
|
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.
|
up to 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年9月9日
初级完成 (实际的)
2020年9月1日
研究完成 (实际的)
2020年9月1日
研究注册日期
首次提交
2015年9月9日
首先提交符合 QC 标准的
2015年9月9日
首次发布 (估计)
2015年9月11日
研究记录更新
最后更新发布 (实际的)
2020年9月22日
上次提交的符合 QC 标准的更新
2020年9月21日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.