NCT02436122

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

3.1 years

First QC Date

May 3, 2015

Last Update Submit

May 17, 2015

Conditions

Prostate NeoplasmPathology

Keywords

Prostate cancerPreoperativeGlycemic controlHemoglobin A1cPathologic outcomesOncological outcomesTreatment OutcomeHemoglobin A1c Protein, Human

Outcome Measures

Primary Outcomes (2)

  • 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

  • Pathological Gleason score

    Gleason scores of prostate cancer specimen described in final pathological report

    within 2 weeks after surgery

Secondary Outcomes (1)

  • Pathological TMN stage

    within 2 weeks after surgery

Eligibility Criteria

Age20 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 6, 2015

Study Start

May 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

KR(1)