Prospective Randomized Trial Comparing Robotic Versus Open Radical Prostatectomy

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365143

Enrollment

Registered

2011-06-03

Start date

2011-05-31

Completion date

2014-02-28

Last updated

2014-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic Neoplasms, Adenocarcinoma

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.

Interventions

PROCEDURERobotic Radical Prostatectomy

Robotic assisted radical prostatectomy

PROCEDUREOpen Radical Prostatectomy

Open radical prostatectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.)

Design outcomes

Primary

Measure	Time frame	Description
Trifecta	at 2 years	Free from biochemical recurrence, continent, and potent 2 years after radical prostatectomy

Secondary

Measure	Time frame	Description
Potency	at 3, 12, and 24 months	Satisfactory erections
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
Continence	at 3, 12, and 24 months	Continent of urine
Estimated blood loss	Participants will be followed for the duration of the operation, an expected average of 3 hours	—
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	—
Long-term complication	>30 days	bladder neck contracture, lymphocele

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026