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

NCT07682584 | Not Yet Recruiting DMC

• 1 other identifier: 20260505112216735
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostate Cancer; Biochemical Recurrence

Outcome Measures

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.

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

Study Arms (1)

RARP Cohort

Consecutive patients with localized prostate cancer who underwent robot-assisted radical prostatectomy (RARP) at Fujian Medical University Affiliated First Hospital between January 2024 and May 2026. Patients are followed postoperatively for biochemical recurrence (BCR). Clinical, imaging, and pathological data are collected to identify predictors of BCR.

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

ZhongHua Zhu

CONTACT

+8618060692924; drzhuzh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: July 15, 2026
• Primary Completion: July 20, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share