- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07682584
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
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: ZhongHua Zhu
- Telefonnummer: +8618060692924
- E-post: drzhuzh@163.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Biochemical Recurrence
Tidsram: From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026
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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.
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From date of surgery until date of confirmed biochemical recurrence, assessed up to 76 months, from January 2020 to May 2026
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20260505112216735
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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