- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: ZhongHua Zhu
- Telefonnummer: +8618060692924
- E-post: drzhuzh@163.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Biochemical Recurrence
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20260505112216735
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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