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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02436122
Other study ID # B-1504-293
Secondary ID
Status Recruiting
Phase N/A
First received May 3, 2015
Last updated May 17, 2015
Start date May 2015
Est. completion date June 2018

Study information

Verified date May 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Kyunggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biochemical recurrence (BCR) 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 postoperative up to 3 years No
Primary Pathological Gleason score Gleason scores of prostate cancer specimen described in final pathological report within 2 weeks after surgery No
Secondary Pathological TMN stage within 2 weeks after surgery No
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