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Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

This study has been terminated.
(Closing due to slow enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365143
First Posted: June 3, 2011
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Prostatic Neoplasms Adenocarcinoma Procedure: Robotic Radical Prostatectomy Procedure: Open Radical Prostatectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Trifecta [ Time Frame: at 2 years ]
    Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy


Secondary Outcome Measures:
  • Continence [ Time Frame: at 3, 12, and 24 months ]
    Continent of urine

  • Potency [ Time Frame: at 3, 12, and 24 months ]
    Satisfactory erections

  • Free from biochemical recurrence [ Time Frame: at 3, 12, and 24 months ]
    PSA <0.2 ng/mL

  • Acute complications [ Time Frame: Within 30 days of surgery ]
    Any complication according to Calvien classification

  • Long-term complication [ Time Frame: >30 days ]
    bladder neck contracture, lymphocele

  • Estimated blood loss [ Time Frame: 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 ]
  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days ]

Enrollment: 10
Study Start Date: May 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365143


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: R. Houston Thompson, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01365143     History of Changes
Other Study ID Numbers: 11-002288
First Submitted: May 26, 2011
First Posted: June 3, 2011
Last Update Posted: June 2, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases