Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Phase 4

Terminated

• Conditions: Prostatic Neoplasms; Adenocarcinoma
• Interventions: Procedure: Open Radical Prostatectomy; Procedure: Robotic Radical Prostatectomy

• Registration Number: NCT01365143
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-03
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 10

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

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Exclusion Criteria

• Previous treatment of prostate cancer (radiation, hormones, etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open Radical Prostatectomy	Open Radical Prostatectomy	-
Robotic radical prostatectomy	Robotic Radical Prostatectomy	-

Primary Outcome Measures

Name	Time	Method
Trifecta	at 2 years	Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy

Secondary Outcome Measures

Name	Time	Method
Operative time	Participants will be followed for the duration of the operation, an expected average of 3 hours
Length of hospital stay	Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days
Continence	at 3, 12, and 24 months	Continent of urine
Free from biochemical recurrence	at 3, 12, and 24 months	PSA \<0.2 ng/mL
Acute complications	Within 30 days of surgery	Any complication according to Calvien classification
Long-term complication	>30 days	bladder neck contracture, lymphocele
Estimated blood loss	Participants will be followed for the duration of the operation, an expected average of 3 hours
Potency	at 3, 12, and 24 months	Satisfactory erections

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States