STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading
研究概览
简要总结
The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.
详细描述
STHLM3 AS NorDCaP is a cross-sectional multi-center study, evaluating the predictive value of Stockholm3 test in a prostate cancer cohort on AS for upgrading on rebiopsy. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional investigations, sampling will be synchronized with timing for planned follow-up within the AS program for each individual.
At baseline blood will be drawn for Stockholm3 analyses. The patient will be asked to fill out an informed consent. For each man the following data will be collected: Stockholm3 Risk Score, Stockholm3 Prostate Volume cut-off, total PSA, DRE status, MRI results (PI-RADS, optional, only if MRI is conducted within 3 months before biopsy), prostate volume, biopsy results (ISUP, cancer length, number of positive cores, total number of cores and stage).
Main outcome measurement will be number of upgrading, i.e. number of detected ISUP ≥ 2 cancers.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men diagnosed with low-risk PC and currently on AS and planned for follow-up with systematic and/or fusion biopsies as following standard of care.
排除标准
- •History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
- •Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
结局指标
主要结局
Validate if the Stockholm3 test can be used in an AS cohort to predict upgrading
时间窗: Through study completion, an average of 1 year
Number of ISUP ≥ 2 prostate cancer
次要结局
未报告次要终点
研究者
Anna Lantz
MD PhD Principal Investigator
Karolinska Institutet