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A Registry to Observe the Treatment of Prostate Cancer Under Routine Medical Care

2019年11月7日更新者：Janssen Pharmaceutica N.V., Belgium

A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

研究概览

地位

完全的

条件

前列腺癌

详细说明

This is a non-interventional, multicenter, prospective registry of patients with a confirmed diagnosis of adenocarcinoma of the prostate presenting with mCRPC, based on documented metastatic prostate cancer and documented castration resistance. Castrate-resistant prostate cancer is defined by disease progression despite testosterone <50 ng/dL, and/or androgen deprivation therapy, and/or a history of orchiectomy, and may present as a continuous rise in prostate-specific antigen (PSA), and/or worsening of existing disease/symptoms, and/or the appearance of new metastases. Observational methodology will be used to capture data. The decision of patients to take part in the registry will not influence their medical care. Treatment decisions will be made at the discretion of the treating physician, per routine clinical practice. Only data available from routine clinical practice will be collected. It is expected that approximately 3,000 patients will participate in this registry. To ensure a patient population representative of clinical practice and to reduce selection bias, all patients meeting the eligibility criteria at a participating site should be consecutively enrolled in the registry, irrespective of their treatment. The planned total duration of the registry will be 5.5 years from the date that the first patient is enrolled, irrespective of the country or registry site. The anticipated duration of patient enrollment is 2.5 years. The maximum duration of follow-up for individual patients in the observational period of the registry will be 3 years, regardless of when they are enrolled. The 3-year period of the observational period will document the sequencing of systemic mCRPC treatments during routine clinical practice, considering the life expectancy of patients with mCRPC in the registry. Unless specified otherwise per local regulations, all patients must give their informed consent to participate in this registry before data collection (ie, data entry into the case report form [CRF]) is performed. Patients will be enrolled at the time of initiation of a new systemic mCRPC treatment or during a period when a patient is considered to be in surveillance according to clinical practice. Baseline data collection will include details of the patient's prostate cancer history and prior prostate cancer treatment. This will be followed by a prospective observational period during which patients may cycle through multiple systemic mCRPC treatment periods and periods of surveillance. During the observational period, data will be collected at the following time points of a patient's course of treatment in routine clinical practice: initiation of a new systemic mCRPC treatment; termination of a systemic mCRPC treatment; when the duration of a systemic mCRPC treatment or surveillance period is >3 months, data collection will be performed at a minimum frequency of 3-monthly intervals during that period. Survival data will be collected for all patients 3 years after their enrollment or at the close of the registry, whichever occurs first, except for those patients who withdraw their consent prior to completing the observation period.

研究类型

观察性的

注册 (实际的)

3050

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

以色列
- - Beer Sheva、以色列
  - Beer Yaakov、以色列
  - Haifa、以色列
  - Holon、以色列
  - Tel-Aviv、以色列
俄罗斯联邦
- - Ekaterinbourg、俄罗斯联邦
  - Moscow N/a、俄罗斯联邦
  - Obninsk、俄罗斯联邦
  - Omsk、俄罗斯联邦
  - Rostov-on-Don、俄罗斯联邦
  - St.-Petersburg、俄罗斯联邦
  - Ufa、俄罗斯联邦
卢森堡
- - Luxembourg、卢森堡
  - Niederkorn、卢森堡
奥地利
- - Salzburg、奥地利
  - Vienna、奥地利
德国
- - Augsburg、德国
  - Bad Saarow、德国
  - Bautzen、德国
  - Berlin、德国
  - Braunschweig、德国
  - Chemnitz、德国
  - Duisburg、德国
  - Erkrath、德国
  - Frankfurt、德国
  - Hamburg、德国
  - Holzminden、德国
  - Jena、德国
  - Kiel、德国
  - Kirchheim、德国
  - Nürtingen、德国
  - Remscheid、德国
  - Reutlingen、德国
  - Rostock、德国
  - Schwerin、德国
  - Sindelfingen、德国
  - Tübingen、德国
  - Ulm、德国
  - Weiden、德国
  - Wilhelmshaven、德国
  - Würselen、德国
斯洛文尼亚
- - Celje、斯洛文尼亚
  - Ljubljana、斯洛文尼亚
  - Slovenj Gradec、斯洛文尼亚
比利时
- - Aalst、比利时
  - Antwerpen、比利时
  - Bonheiden、比利时
  - Brasschaat、比利时
  - Brugge、比利时
  - Edegem、比利时
  - Gent、比利时
  - Kortrijk、比利时
  - Liège、比利时
  - Oostende、比利时
  - Ottignies、比利时
  - Roeselare、比利时
  - Turnhout、比利时
法国
- - Angers、法国
  - Avignon Cedex 9、法国
  - Brest、法国
  - Béziers、法国
  - GAP、法国
  - Hyeres、法国
  - La Tronche、法国
  - Marseille、法国
  - Metz、法国
  - Montpellier、法国
  - Nancy、法国
  - Paris、法国
  - Perigueux、法国
  - Pierre Benite Cedex、法国
  - Pringy、法国
  - Reims Cedex、法国
  - Rennes cedex 09、法国
  - Saint Mande、法国
  - St Gregoire Cedex、法国
  - St Quentin Cedex、法国
  - Toulouse、法国
  - Tours Cedex、法国
波兰
- - Bydgoszcz、波兰
  - Gdynia、波兰
  - Krakow、波兰
  - Lodz、波兰
  - Opole、波兰
  - Poznañ、波兰
  - Warsaw、波兰
  - Warszawa、波兰
火鸡
- - Ankara、火鸡
  - Edirne、火鸡
  - Istanbul、火鸡
  - Izmir、火鸡
  - Kayseri、火鸡
  - Kocaeli、火鸡
  - Turkey、火鸡
瑞典
- - Borås、瑞典
  - Göteborg、瑞典
  - Malmö、瑞典
  - Stockholm、瑞典
  - Umeå、瑞典
  - Västerås、瑞典
  - Växjö、瑞典
  - Örebro、瑞典
  - Östersund、瑞典
瑞士
- - Aarau、瑞士
  - Winterthur、瑞士
英国
- - Ashton Under Lyne、英国
  - Barnstaple、英国
  - Blackburn、英国
  - Bournemouth、英国
  - Bradford、英国
  - Brighton Sussex、英国
  - Burton、英国
  - Crewe、英国
  - Huddersfield、英国
  - Lancaster、英国
  - Leeds Yorks、英国
  - London、英国
  - N/a N/a、英国
  - Plymouth、英国
  - Scunthorpe、英国
  - Steeton、英国
  - Stoke On Trent、英国
  - Taunton、英国
  - Torquay、英国
  - Wakefield、英国
  - Wigan、英国
  - York、英国
葡萄牙
- - Braga、葡萄牙
  - Coimbra、葡萄牙
  - Evora、葡萄牙
  - Lisboa、葡萄牙
  - Porto、葡萄牙
  - Setubal、葡萄牙
西班牙
- - Asturias、西班牙
  - Barakaldo Vizcaya、西班牙
  - Barcelona、西班牙
  - Bilbao Vizcaya、西班牙
  - Girona、西班牙
  - La Coruña、西班牙
  - Langreo、西班牙
  - Palma De Mallorca、西班牙
  - Pontevedra、西班牙
  - Sabadell、西班牙
  - Salamanca、西班牙
  - Santiago de Compostela、西班牙
  - Valladolid、西班牙
  - Zaragoza、西班牙

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

18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

概率样本

研究人群

Approximately 3,000 patients will be enrolled in this registry. Patients eligible for enrollment will be men aged at least 18 years, with a confirmed diagnosis of adenocarcinoma of the prostate, with documented metastatic prostate cancer and documented castration resistance. Patients will be enrolled at the time of initiating a new systemic anticancer mCRPC treatment or during surveillance; for the purpose of the registry, at enrollment, initiation of a new systemic mCRPC treatment is considered as ±30 days from a patient's baseline data collection.

描述

Inclusion Criteria:

Patients with a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate Patients with documented metastatic prostate cancer Patients with documented castration resistance Patients either: Initiating a new systemic mCRPC treatment; or considered to be in surveillance according to clinical practice Sign (or their legally-acceptable representatives must sign) a participation agreement or informed consent form (ICF), per local regulations.

Exclusion Criteria:

Any patient who is withdrawn from the registry for any reason may not re-enter the registry

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

队列和干预

团体/队列团体/队列观察性研究中评估生物医学或健康结果的一组或一组参与者。
mCRPC patients Patients with metastatic castration-resistant prostate cancer treated according to routine clinical practice

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
Sequencing of treatment initiation, termination, and duration 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	During the registry all systemic mCRPC therapies, corticoids for systemic use in the context of prostate cancer treatment and local mCRPC therapies, including but not limited to urologic surgery, orthopaedic surgery, and local radiotherapy, will be documented.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years

次要结果测量

结果测量	措施说明	大体时间
Clinical Benefit 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Clinical benefit will be based on the Eastern Cooperative Oncology Group (ECOG) performance status, which measure the patient status on a scale from 0 (fully active) to 5 (dead).	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Medical Resource Utilization 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Total number of days of hospitalization due to prostate cancer, or treatment of the disease, total number of visits to an emergency room due to prostate cancer, or treatment of the disease, and total number of outpatient visits due to prostate cancer, or treatment of the disease	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
European Quality of Life-5 Dimensions, 5 Levels Questionnaire (EQ-5D-(5L)) 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	The EQ-5D-5L is an instrument for measuring health status. It consists of the descriptive system and the EQ visual Analogue scale (EQ VAS). The descriptive system comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, and anxiety/depression). There are 5 levels for each dimension: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labeled 'the best health you can imagine' and 'the worst health you can imagine'.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Functional Assessment of Cancer Therapy - Prostate Cancer (FACT-P) 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	The FACT-P consists of the FACT-General (FACT-G) and a prostate cancer subscale. The FACT-G (Version 4) contains a 27-item questionnaire and is composed of 4 subscales of health-related quality-of-life: physical well-being, social/family well-being, emotional well being, and functional well-being. The prostate cancer subscale is composed of 12 items, related to prostate-specific questions, which include sexuality, bowel/bladder function, and pain. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to 156; a higher score indicates better QOL	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Overall Survival 大体时间：At treatment initiation/termination or every 3 months from baseline to 3 years		At treatment initiation/termination or every 3 months from baseline to 3 years
Radiologic Assessment 大体时间：At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years	Radiologic assessment methodology and radiologic response will be documented. Prostate Cancer Working Group 2 (PCWG2) and Response Evaluation Criteria In Solid Tumor (RECIST) are recommended guidelines for assessment.	At baseline, at treatment initiation/termination and at least every 3 months during maximum 3 years
Prior prostate cancer treatment 大体时间：At baseline	Prior prostate cancer treatment (local and systemic therapy) from the time of diagnosis of prostate cancer to entry in the registry will be recorded.	At baseline
Reason for start and rationale for choice of treatment 大体时间：At treatment initiation during maximum 3 years		At treatment initiation during maximum 3 years
Reason for treatment discontinuation 大体时间：At treatment discontinuation during maximum 3 years		At treatment discontinuation during maximum 3 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。

赞助

Janssen Pharmaceutica N.V., Belgium

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

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)

2013年6月14日

初级完成 (实际的)

2018年11月21日

研究完成 (实际的)

2018年11月21日

研究注册日期

首次提交

2014年9月8日

首先提交符合 QC 标准的

2014年9月9日

首次发布 (估计)

2014年9月10日

研究记录更新

最后更新发布 (实际的)

2019年11月12日

上次提交的符合 QC 标准的更新

2019年11月7日

最后验证

2019年11月1日