Prospective Prostate Cancer Infrastructure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Treatment patterns
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not currently living in the Netherlands.
结局指标
主要结局
Treatment patterns
时间窗: 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.
PSA response
时间窗: 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.
PSA nadir
时间窗: 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.
Utilization of imaging modalities for primary staging
时间窗: At baseline
Type and frequency of imaging modalities used at primary staging, including PSMA PET/CT, conventional CT, bone scintigraphy, and MRI.
Time to clinical progression
时间窗: 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.
Time to biochemical progression
时间窗: 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.
Time to radiographic progression
时间窗: 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.
Time to castration-resistant prostate cancer (CRPC)
时间窗: From treatment initiation through study completion, up to 4 years
Time from treatment initiation to castration-resistant prostate cancer (CRPC) per PCWG3 criteria.
Overall survival
时间窗: From diagnosis through study completion, up to 4 years
Time from diagnosis to death from any cause.
Adverse events
时间窗: 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.
Number of hospital admissions
时间窗: From treatment initiation through study completion, up to 4 years
Total number of planned and unplanned hospital admissions.
Number of outpatient visits
时间窗: From treatment initiation through study completion, up to 4 years
Total number of outpatient visits
次要结局
- Dynamic change in ctDNA fraction(Change from baseline at 4-6 weeks, and 9 months after start of initial treatment.)
- Prevalence and clinical phenotypes of genomic alterations(At diagnosis or at disease progression, up to 4 years)
- Health-Related Quality of Life (Global Health Status)(Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.)
- Health-Related Quality of Life (Health Utility)(Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months)
- Pain intensity and interference(Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.)
- Fatigue severity and interference(Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.)
- Prostate cancer-specific symptoms(Change from baseline at 3, 6, 9, 12, 18, 24, 30, 36, and 48 months.)