- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01365143
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
-
-
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
|
Open radical prostatectomy
|
Active Comparator: 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
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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