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

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.

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Key information

Conditions

Prostate Cancer Biochemical Recurrence Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

ZhongHua Zhu

CONTACT

[email protected]

+8618060692924

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 6, 2026
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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