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Prospective Prostate Cancer Infrastructure (ProPCI)

2026年9月4日更新者：Radboud University Medical Center

The goal of this observational study is to collect detailed long-term real-world data and biomaterials from men with high-risk localized prostate cancer and synchronous metastatic hormone-sensitive prostate cancer. This will help to better understand how these patients are treated in daily practice, how treatments affect quality of life, and facilitate biomarker discovery. The infrastructure is also designed to enable future cohort multiple randomized controlled trials.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

700

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。

学习联系方式

姓名：Niven Mehra, PhD
电话号码：+3124 361 88 00
邮箱：niven.mehra@radboudumc.nl

学习地点

荷兰
- - Nijmegen、荷兰
    - 招聘中
    - Radboud University Medical Center

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

成人
年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

All patients with treatment-naive high-risk localized and treatment-naive metastatic prostate carcinoma will be eligible to participate. These patients are identified by their treating physicians in all participating hospitals.

描述

Inclusion Criteria:

Diagnosis of either: high-risk localized prostate cancer (any of the following: PSA > 20 ng/mL, ISUP Grade Group 4 or 5, or clinical stage ≥ T2c); or metastatic prostate cancer confirmed by imaging (CT, bone scintigraphy, PSMA PET/CT, or (whole-body) MRI in combination with tumor markers (PSA)), or by biopsy of a metastatic lesion histopathologically deemed to be of prostatic origin.
Prostate adenocarcinoma (our main focus). We will allow the inclusion of adenocarcinoma with mixed small- or large-cell neuroendocrine prostate
Age ≥ 18 years at the time of inclusion.
Written informed consent
Able to understand one of the following languages sufficiently: Dutch, English, Arabic or Turkish.

Exclusion Criteria:

Not currently living in the Netherlands.

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

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
Treatment patterns 大体时间：From diagnosis through study completion, up to 4 years	Documentation of initial and sequential treatment strategies, including type, timing, and combination of androgen deprivation therapy, androgen receptor pathway inhibitors, chemotherapy, and radiotherapy, within 4 months and beyond 4 months after diagnosis.	From diagnosis through study completion, up to 4 years
PSA response 大体时间：From treatment initiation up to 12 months.	Proportion of patients achieving >50% and >90% PSA decline from baseline within the first year after treatment initiation.	From treatment initiation up to 12 months.
PSA nadir 大体时间：From treatment initiation up to 12 months	Lowest PSA value achieved within 1 year after treatment initiation and time from treatment initiation to PSA nadir.	From treatment initiation up to 12 months
Utilization of imaging modalities for primary staging 大体时间：At baseline	Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.	At baseline
Time to clinical progression 大体时间：From treatment initiation through study completion, up to 4 years	Time from treatment initiation to clinical progression, defined as local progression, and/or symptomatic skeletal events (pain, fracture, spinal cord compression), or initiation of surgery or radiotherapy for progression.	From treatment initiation through study completion, up to 4 years
Time to biochemical progression 大体时间：From treatment initiation through study completion, up to 4 years	Time from treatment initiation to biochemical progression per PCWG3 criteria, defined as a minimum PSA rise of 25% AND an absolute increase of 2ng/mL from the nadir, confirmed on two measurements ≥3 weeks apart.	From treatment initiation through study completion, up to 4 years
Time to radiographic progression 大体时间：From treatment initiation through study completion, up to 4 years	Time from treatment initiation to radiographic progression based on imaging (conventional imaging, PSMA PET/CT), or RECIST 1.1 criteria.	From treatment initiation through study completion, up to 4 years
Time to castration-resistant prostate cancer (CRPC) 大体时间：From treatment initiation through study completion, up to 4 years	Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.	From treatment initiation through study completion, up to 4 years
Overall survival 大体时间：From diagnosis through study completion, up to 4 years	Time from diagnosis to death from any cause.	From diagnosis through study completion, up to 4 years
Adverse events 大体时间：From treatment initiation through study completion, up to 4 years	Type, grade, and treatment-relatedness of adverse events occurring during treatment, graded according to the Common Terminology Criteria for Adverse Events version 5.0.	From treatment initiation through study completion, up to 4 years
Number of hospital admissions 大体时间：From treatment initiation through study completion, up to 4 years	Total number of planned and unplanned hospital admissions.	From treatment initiation through study completion, up to 4 years
Number of outpatient visits 大体时间：From treatment initiation through study completion, up to 4 years	Total number of outpatient visits	From treatment initiation through study completion, up to 4 years

次要结果测量

结果测量	措施说明	大体时间
Dynamic change in ctDNA fraction 大体时间：Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.	Change in ctDNA fraction at 4-6 weeks and 9 months after start of initial treatment.	Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.
Prevalence and clinical phenotypes of genomic alterations 大体时间：At diagnosis or at disease progression, up to 4 years	Prevalence and clinical phenotype associations of somatic alterations in prostate cancer related genes and (likely) pathogenic germline variants, detected by cfDNA or tumor tissue.	At diagnosis or at disease progression, up to 4 years
Health-Related Quality of Life (Global Health Status) 大体时间：Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.	Clinically meaningful change in Global Health Status using the EORTC QLQ-C30 as a measure for Health Related Quality of Life, from baseline to sequential follow-up.	Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Health-Related Quality of Life (Health Utility) 大体时间：Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months	Change in health utility index and EQ Visual Analogue Scale score measured using the EQ-5D-5L, across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months
Pain intensity and interference 大体时间：Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.	Change in average pain score and pain interference score measured using the Brief Pain Inventory - Short Form (BPI-SF).	Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Fatigue severity and interference 大体时间：Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.	Change in average fatigue score and fatigue interference score measured using the Brief Fatigue Inventory (BFI).	Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.
Prostate cancer-specific symptoms 大体时间：Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.	Change in prostate cancer-specific symptoms measured using the EORTC QLQ-PR25, domain scores for urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity, and sexual functioning.	Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.

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

Radboud University Medical Center

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)

2026年9月1日

初级完成 (估计的)

2030年9月1日

研究完成 (估计的)

2030年9月1日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月4日

最后验证