Pathology Clinical Trial
Official title:
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
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.
- 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.
;
Observational Model: Cohort, Time Perspective: Prospective
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