Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Prostatic Neoplasms Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01365143
• Other study ID #: 11-002288
• Status: Terminated
• Phase: Phase 4
• First received: May 26, 2011
• Last updated: May 30, 2014
• Start date: May 2011
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostatic Neoplasms

Intervention

Procedure:
• Robotic Radical Prostatectomy
Robotic assisted radical prostatectomy
• Open Radical Prostatectomy
Open radical prostatectomy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trifecta	Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy	at 2 years	No
Secondary	Continence	Continent of urine	at 3, 12, and 24 months	No
Secondary	Potency	Satisfactory erections	at 3, 12, and 24 months	No
Secondary	Free from biochemical recurrence	PSA <0.2 ng/mL	at 3, 12, and 24 months	No
Secondary	Acute complications	Any complication according to Calvien classification	Within 30 days of surgery	No
Secondary	Long-term complication	bladder neck contracture, lymphocele	>30 days	No
Secondary	Estimated blood loss		Participants will be followed for the duration of the operation, an expected average of 3 hours	No
Secondary	Operative time		Participants will be followed for the duration of the operation, an expected average of 3 hours	No
Secondary	Length of hospital stay		Participants will be followed for the duration of the hospital stay, an expected average of 1-2 days	No