Prospective Cohort Study for the Impact of Preoperative Glycemic Control Status Measured by HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Pathological Gleason score
研究概览
简要总结
The effect of preoperative glycemic control measured by HbA1c on prostate cancer (PCa) outcome remains controversial. Thus, the investigators aim to examine the association of preoperative glycemic control with oncologic outcomes after radical prostatectomy (RP).
The investigators will prospectively collect the relevant data including preoperative HbA1c in 264 patients of PCa patients undergoing RP. The associations between clinical variables and risk of adverse pathological features and disease recurrence will be tested using a multivariate logistic regression and multiple Cox-proportional hazards model, respectively.
详细描述
- This is the observational study as the single institutional, prospective cohort study. The investigators prospectively collect the clinicopathological information of the patients with prostate cancer (PCa) undergoing radical prostatectomy (RP).
- Particularly, the investigators check the variables, including age at surgery, body mass index, comorbidities, preoperative PSA levels, prostate volume measured by TRUS, preoperative HbA1c levels, biopsy Gleason score, positive biopsy cores, percent positive cores, clinical TMN staging, final pathological results (TMN stage, Gleason score, extraprostatic extension, seminal vesicle invasion, surgical margin positivity, postoperative biochemical recurrence (BCR), local recurrence, and distant metastasis during follow-up periods.
- The study protocol is same with routine follow-up schedule of the patients with PCa treated with RP. Typically, the investigators check the patients at 1, 3, 6, 9, 12, 18, 24, 30 and 36 months. However, according to the patients status and preference, follow-up schedule can be changed within 3 months at specific time points. Because the present study is the observational cohort study, not intervention study, subtle changes of follow-up schedule would not affect on the primary outcomes.
- Importantly, preoperative HbA1c should be checked within 1 month before operation, same as the routine preoperative laboratory tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer diagnosed with prostate biopsy
- •Clinically localized PCa confirmed by prostate MRI and Bone scan
- •Patients undergoing RP
排除标准
- •Distant metastasis, preoperatively
- •Preoperative hormone therapy
- •Preoperative chemotherapy
- •Radiation therapy
- •Medications affecting glucose status other than diabetes mellitus
结局指标
主要结局
Pathological Gleason score
时间窗: within 2 weeks after surgery
Gleason scores of prostate cancer specimen described in final pathological report
Biochemical recurrence (BCR)
时间窗: postoperative up to 3 years
BCR was defined as either two consecutive increases in serum PSA (\>0.2 ng/mL) or the administration of adjuvant therapy during the postoperative follow-up period
次要结局
- Pathological TMN stage(within 2 weeks after surgery)
研究者
Sung Kyu Hong
Associate professor
Seoul National University Hospital