Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

NCT ID: NCT01365143

Last Updated: 2014-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Prostatic Neoplasms Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Radical Prostatectomy

Group Type ACTIVE_COMPARATOR

Open Radical Prostatectomy

Intervention Type PROCEDURE

Open radical prostatectomy

Robotic radical prostatectomy

Group Type ACTIVE_COMPARATOR

Robotic Radical Prostatectomy

Intervention Type PROCEDURE

Robotic assisted radical prostatectomy

Interventions

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Robotic Radical Prostatectomy

Robotic assisted radical prostatectomy

Intervention Type PROCEDURE

Open Radical Prostatectomy

Open radical prostatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-002288

Identifier Type: -

Identifier Source: org_study_id

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