NCT01643954

Brief Summary

This is a retrospective/prospective Analysis of surgical outcomes of robotic prostatectomy.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,531

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
15mo left

Started Sep 2008

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress93%
Sep 2008Jul 2027

Study Start

First participant enrolled

September 23, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

18.9 years

First QC Date

May 8, 2012

Last Update Submit

December 24, 2025

Conditions

Keywords

prostatectomysurgeryprostate cancer

Outcome Measures

Primary Outcomes (1)

  • Collect and analyze descriptive characteristics of patient population and summarize patient outcome data.

    up to 20 years

Secondary Outcomes (4)

  • Correlate the patient characteristics to the surgical outcomes.

    up to 20 years

  • Determine the overall survival

    up to 20 years

  • Determine the rate of local recurrence in patients undergoing robotic prostatectomy and compare these metrics to historical controls.

    up to 20 years

  • disease- free survival

    up to 20 years

Study Arms (2)

Arm A

NO INTERVENTION

Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.

Arm B

OTHER

Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center .

Procedure: robotic radical prostatectomy

Interventions

robotic assisted surgery

Also known as: laparoscopic surgery, The da Vinci system
Arm B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with prostate cancer who have undergone robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • years and older
  • ARM B:
  • Patients with prostate cancer that will undergo robotic radical prostatectomy at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center.
  • Ability to understand and willingness to sign the written informed consent document.
  • years and older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Steven Clinton, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2012

First Posted

July 18, 2012

Study Start

September 23, 2008

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations