Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer Based on USTC Diagnostic Model and PSA Level: a Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- prostate cancer diagnostic free survival time
研究概览
简要总结
The goal of this observational study is to evaluate the role of the USTC diagnostic model in risk-adaptive strategies for biopsy decision-making in patients with low-risk suspected prostate cancer in order to reduce unnecessary biopsy. Based on the USTC diagnostic model (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) and serum PSA levels, patients with low-risk suspected prostate cancer are enrolled and received active surveillance rather than biopsy. The main questions to be answered is:
• The safety and feasibility of conducting biopsy-free active monitoring in patients with low-risk suspected prostate cancer accessed by the USTC diagnostic model and serum PSA levels.
Participants will be required to undergo serum PSA testing every 3 months, mpMRI testing every 6 months, and reassessment of the probability of developing prostate cancer using the USTC model every 3 months. Patients who do not meet the inclusion criteria and are at increased risk will no longer receive active surveillance and will be advised to undergo biopsy. Dynamic changes in PI-RADS score and biopsy results will also be recorded.
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
- •Patients with clinically suspected PCa have indications for prostate biopsy;
- •Complete serum PSA testing and mpMRI examination in the outpatient department;
- •4 ng/ml ≤ serum total PSA ≤10 ng/ml;
- •The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05;
- •There is no family history of prostate cancer and no history of other malignant tumors.
排除标准
- •The patient has previous history of prostate biopsy;
- •Lack of complete clinical information, such as failure to perform mpMRI;
- •Patients with serum total PSA < 4ng/ml or > 10ng/ml.
- •According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05.
结局指标
主要结局
prostate cancer diagnostic free survival time
时间窗: through study completion, an average of 2 year
survival analysis by K-M curves and log-rank tests
次要结局
- dynamic change of serum total PSA(every 3 months up to 2 years)
- dynamic change of PI-RADS score(every 6 months up to 2 years)
研究者
TaoTao
Associate professor, Associate chief physician
Anhui Provincial Hospital