Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Prostatic Neoplasms; Adenocarcinoma

Treatments: Procedure: Robotic Radical Prostatectomy; Procedure: Open Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01365143

11-002288

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Open Radical Prostatectomy

Active Comparator group

Treatment:

Procedure: Open Radical Prostatectomy

Robotic radical prostatectomy

Active Comparator group

Treatment:

Procedure: Robotic Radical Prostatectomy