- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: ZhongHua Zhu
- 전화번호: +8618060692924
- 이메일: drzhuzh@163.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Biochemical Recurrence
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20260505112216735
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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