Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Biochemical Recurrence
研究概览
简要总结
This retrospective study aims to identify predictive factors for biochemical recurrence (BCR) in patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP). BCR is defined as a rise in prostate-specific antigen (PSA) levels after surgery, which may indicate residual or recurrent disease.
We will analyze clinical, imaging, and pathological data from patients treated at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Key variables include preoperative PSA, Gleason score, pathological T stage, surgical margin status, perineural invasion, prostate volume, MRI-based parameters (e.g., Pi-RADS score, SUVmax on PSMA PET/CT), and inflammatory markers.
Using logistic regression and machine learning approaches (random forest, XGBoost, SVM), we will develop and internally validate a predictive model to estimate individual BCR risk. The goal is to improve post-surgical risk stratification, guide personalized monitoring, and support clinical decision-making regarding adjuvant therapy.
This research has received ethical approval. Data will be anonymized and handled confidentially. Findings will be disseminated to inform clinical practice and future research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed prostate adenocarcinoma
- •Clinical stage localized prostate cancer (T1-T2, N0M0)
- •Underwent robot-assisted radical prostatectomy (RARP)
- •Age ≥ 18 years
- •Complete clinical data including preoperative PSA, Gleason score, pathological T stage, and surgical margin status
- •At least one postoperative PSA measurement available to determine biochemical recurrence status
- •Signed informed consent for surgery and data use (or ethics committee waiver of consent for retrospective analysis)
排除标准
- •Received neoadjuvant endocrine therapy, radiotherapy, or chemotherapy prior to surgery
- •Concurrent active malignancy other than non-melanoma skin cancer
- •Preoperative evidence of lymph node metastasis (N+), distant metastasis (M1), or clinical stage T3-T4
- •Missing core predictors (e.g., preoperative PSA, Gleason score, pathological T stage) or insufficient postoperative PSA data to determine BCR status
- •Received adjuvant radiotherapy or adjuvant endocrine therapy before biochemical recurrence was determined
- •Severe cardiac, hepatic, or renal dysfunction, or life expectancy < 1 year
结局指标
主要结局
Biochemical Recurrence
时间窗: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026
Biochemical recurrence (BCR) is defined as a postoperative serum prostate-specific antigen (PSA) level of ≥0.2 ng/mL on two consecutive measurements, with the second measurement confirming the elevation. This is the primary outcome event for the study, used to distinguish patients with recurrence from those without recurrence during follow-up.
次要结局
未报告次要终点