Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

May 30, 2014 updated by: Mayo Clinic
To date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. For patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. This study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Biopsy proven adenocarcinoma of the prostate
  • Deemed a surgical candidate for a bilateral nerve bundle preservation
  • Potent
  • Continent of urine
  • Surgical candidate for both open and robotic nerve-sparing radical prostatectomy
  • Age >18

Exclusion Criteria:

  • Previous treatment of prostate cancer (radiation, hormones, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open Radical Prostatectomy
Procedure: Open Radical Prostatectomy
Open radical prostatectomy
Active Comparator: Robotic radical prostatectomy
Procedure: Robotic Radical Prostatectomy
Robotic assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trifecta
Time Frame: at 2 years
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy
at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continence
Time Frame: at 3, 12, and 24 months
Continent of urine
at 3, 12, and 24 months
Potency
Time Frame: at 3, 12, and 24 months
Satisfactory erections
at 3, 12, and 24 months
Free from biochemical recurrence
Time Frame: at 3, 12, and 24 months
PSA <0.2 ng/mL
at 3, 12, and 24 months
Acute complications
Time Frame: Within 30 days of surgery
Any complication according to Calvien classification
Within 30 days of surgery
Long-term complication
Time Frame: >30 days
bladder neck contracture, lymphocele
>30 days
Estimated blood loss
Time Frame: Participants will be followed for the duration of the operation, an expected average of 3 hours
Participants will be followed for the duration of the operation, an expected average of 3 hours
Operative time
Time Frame: Participants will be followed for the duration of the operation, an expected average of 3 hours
Participants will be followed for the duration of the operation, an expected average of 3 hours
Length of hospital stay
Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days
Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

June 1, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002288

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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