Clinical trial NCT02436122: Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Neoplasm
Pathology
Keywords: Prostate cancer
Preoperative
Glycemic control
Hemoglobin A1c
Pathologic outcomes
Oncological outcomes
Treatment Outcome
Hemoglobin A1c Protein, Human
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 264
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled patients should be diagnosed with prostate cancer by TRUS-guided 12 cores biopsy. In addition, the participants should be treated with radical prostatectomy.

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer diagnosed with prostate biopsy
* Clinically localized PCa confirmed by prostate MRI and Bone scan
* Patients undergoing RP

Exclusion Criteria:

* Distant metastasis, preoperatively
* Preoperative hormone therapy
* Preoperative chemotherapy
* Radiation therapy
* Medications affecting glucose status other than diabetes mellitus

Primary outcomes:
measure: Biochemical recurrence (BCR)
timeFrame: postoperative up to 3 years
measure: Pathological Gleason score
timeFrame: within 2 weeks after surgery
Secondary outcomes:
measure: Pathological TMN stage
timeFrame: within 2 weeks after surgery
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyunggi-do
Study officials:
References: