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Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Primary Purpose

Prostatic Neoplasms, Adenocarcinoma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Robotic Radical Prostatectomy
Open Radical Prostatectomy
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open Radical Prostatectomy

Robotic radical prostatectomy

Arm Description

Outcomes

Primary Outcome Measures

Trifecta
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy

Secondary Outcome Measures

Continence
Continent of urine
Potency
Satisfactory erections
Free from biochemical recurrence
PSA <0.2 ng/mL
Acute complications
Any complication according to Calvien classification
Long-term complication
bladder neck contracture, lymphocele
Estimated blood loss
Operative time
Length of hospital stay

Full Information

First Posted
May 26, 2011
Last Updated
May 30, 2014
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01365143
Brief Title
Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Closing due to slow enrollment
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Radical Prostatectomy
Arm Type
Active Comparator
Arm Title
Robotic radical prostatectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Robotic Radical Prostatectomy
Intervention Description
Robotic assisted radical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Open Radical Prostatectomy
Intervention Description
Open radical prostatectomy
Primary Outcome Measure Information:
Title
Trifecta
Description
Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy
Time Frame
at 2 years
Secondary Outcome Measure Information:
Title
Continence
Description
Continent of urine
Time Frame
at 3, 12, and 24 months
Title
Potency
Description
Satisfactory erections
Time Frame
at 3, 12, and 24 months
Title
Free from biochemical recurrence
Description
PSA <0.2 ng/mL
Time Frame
at 3, 12, and 24 months
Title
Acute complications
Description
Any complication according to Calvien classification
Time Frame
Within 30 days of surgery
Title
Long-term complication
Description
bladder neck contracture, lymphocele
Time Frame
>30 days
Title
Estimated blood loss
Time Frame
Participants will be followed for the duration of the operation, an expected average of 3 hours
Title
Operative time
Time Frame
Participants will be followed for the duration of the operation, an expected average of 3 hours
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

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