Predictors of BCR After RARP for Localized Prostate Cancer: A Retrospective Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Biochemical Recurrence. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis
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.
Primary outcome measures
- Biochemical Recurrence [Time frame: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07682584 · 20260505112216735