Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,500
- 试验地点
- 1
- 主要终点
- Failure-free survival
研究概览
简要总结
This project's objective is to initiate a prospective non-interventional clinical study to perform full molecular characterization and subtyping of the primary tumor prostate cancer patients.
It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.
详细描述
This prospective study includes molecular characterization of the primary tumor, biobanking of urine and blood, questionnaires, collection of health economic parameters, cross-checking of registries to link both other diagnoses and drug use to the different biomarkers and socio-economic parameters.
Clinical variables including imaging and routine pathology and the outcome of the molecular diagnostic analysis should, in addition to the basic scientific purpose, also be able to identify men who may be eligible for other studies, both pharmaceutical company-funded and investigator-initiated studies.
One aim is also to develop the national medical information system already in place for prostate cancer (individual patient record) with molecular profiling and other variables for health estimation, health economics and also enable retrieval from more registries.
This study will form the basis for the start of a nationwide study with the aim to prioritize biomarkers for the development of treatment predictive algorithms
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
- •Men investigated for suspected prostate cancer
- •Signed consent form
排除标准
- •Difficulties understanding information about the study due to linguistic, cognitive or other reason
研究组 & 干预措施
Non-metastatic high-risk prostate cancer
ISUP ≥4, T3-4, or regional lymph node positive
干预措施: High-risk treatment SOC (Other)
Low risk prostate cancer
ISUP = 1, PSA <10 µg/L, PSA-density <0,15 µg/l/cm3
干预措施: Active monitoring (Other)
Medium risk prostate cancer
ISUP 2-3, PSA 10-20 µg/L
干预措施: Radical prostatectomy (Procedure)
Medium risk prostate cancer
ISUP 2-3, PSA 10-20 µg/L
干预措施: Radiotherapy (Radiation)
Metastatic prostate cancer
PSA > 80 µg/L, clinically manifest metastases
干预措施: Androgen deprivation therapy (Drug)
结局指标
主要结局
Failure-free survival
时间窗: From enrollment to 20 years failure-free survival
次要结局
- Biomarker profiling(From enrollment to 20 years.)
- EORTC QLQ-C15-PAL(From enrollment to 20 years.)
- IPSS(From enrollment to 20 years)
- Costs for implementing precision medicine(Before and after implementation of precision medicine workflows)
- Cost effectiveness analysis(From enrollment to 20 years)
研究者
Andreas Josefsson
Associate Professor / Urologist
Region Västerbotten