NCT01173952

Brief Summary

This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 30, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 2, 2010

Status Verified

June 1, 2010

Enrollment Period

3.3 years

First QC Date

July 30, 2010

Last Update Submit

July 30, 2010

Conditions

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with prostate cancer

You may qualify if:

  • Pathologic diagnosis of prostate adenocarcinoma
  • Clinical stage: AJCC (VI) stage T1-T2 N0M0
  • Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy

You may not qualify if:

  • Clinical Stage: T3, T4, nodal or distant metastasis
  • All kind of neoadjuvant, concurrent and adjuvant treatment
  • poor health forced a patient into dropout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sung Won Lee, M.D.& Ph.D.

    Department of Urology Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Sung Won Lee, M.D.& Ph.D.

CONTACT

Deok Hyun Han, M.D.& Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 2, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

August 2, 2010

Record last verified: 2010-06