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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically confirmed prostate adenocarcinoma

Disqualifiers

Received neoadjuvant endocrine therapy, radiotherapy, or chemotherapy prior to surgery

Trial population

All patients with localized prostate adenocarcinoma (clinical stage T1-T2, N0M0) who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2020 and May 2026. Consecutive patients meeting eligibility criteria are included. No specific sampling frame or probability sampling method is applied.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: RARP Cohort

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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