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Not yet recruiting NCT07682584

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

Observational Prostate Cancer Biochemical Recurrence

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗