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Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01365143
First received: May 26, 2011
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Trifecta [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
    Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy


Secondary Outcome Measures:
  • Continence [ Time Frame: at 3, 12, and 24 months ] [ Designated as safety issue: No ]
    Continent of urine

  • Potency [ Time Frame: at 3, 12, and 24 months ] [ Designated as safety issue: No ]
    Satisfactory erections

  • Free from biochemical recurrence [ Time Frame: at 3, 12, and 24 months ] [ Designated as safety issue: No ]
    PSA <0.2 ng/mL

  • Acute complications [ Time Frame: Within 30 days of surgery ] [ Designated as safety issue: No ]
    Any complication according to Calvien classification

  • Long-term complication [ Time Frame: >30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Operative time [ Time Frame: Participants will be followed for the duration of the operation, an expected average of 3 hours ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 454
Study Start Date: May 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365143

Contacts
Contact: R. Houston Thompson, MD 507-284-3982 thompson.robert@mayo.edu
Contact: Matthew Tollefson, MD 507-284-3982 tollefson.matthew@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: R. Houston Thompson, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01365143     History of Changes
Other Study ID Numbers: IRB# 11-002288
Study First Received: May 26, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013