Predictors of BCR After RARP for Localized Prostate Cancer: A Retrospective Analysis

N/ANot Yet RecruitingNCT07682584

First Affiliated Hospital of Fujian Medical University200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Prostate Cancer Biochemical Recurrence

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Biochemical Recurrence

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.

Time frame: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026