NCT07682584Not yet recruiting
Predictors of BCR After RARP for Localized Prostate Cancer: A Retrospective Analysis
Predictors of Biochemical Recurrence After Robot-Assisted Radical Prostatectomy in Patients With Localized Prostate Cancer: A Retrospective Analysis
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 28 Jun 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 20 Jul 2026
- Lead sponsor
- First Affiliated Hospital of Fujian Medical University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07682584
What you commit to
- Study type: Observational
- Planned participants: 200
- From 15 Jul 2026 to the primary completion date, 20 Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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)
Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.