Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform (URO-ROBOT-2023)

HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN).

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Cancer; Prostate Cancer (Adenocarcinoma)
• Intervention / Treatment: Procedure: Radical prostatectomy; Procedure: Partial nephrectomy

Detailed Description

The study is designed as a single-center, prospective, interventional, non-pharmacological, randomized, open-label, controlled trial with parallel groups. It targets patients with prostate cancer or kidney cancer who are candidates for robot-assisted surgical treatment, specifically radical prostatectomy (RP) or partial nephrectomy (PN). The study is divided into a patient enrolment and robot-assisted treatment phase, followed by a phase of oncological and functional follow-up. Once enrolled, patients will be randomized to undergo treatment using either the Da Vinci Xi platform (Intuitive Surgical) or the HUGO™ RAS platform (Medtronic) according to block randomization.

Patients with prostate cancer (Group A), enrolled according to inclusion criteria, will be randomized to undergo RP treatment with the Da Vinci Xi platform (control group) or RP treatment with the HUGO™ RAS platform (study group).

Patients with kidney cancer (Group B), enrolled according to inclusion criteria, will be randomized to undergo PN treatment with the Da Vinci Xi platform or PN treatment with the HUGO™ RAS platform.

If the surgical, oncological, and functional outcomes observed following radical prostatectomy and partial nephrectomy performed with the HUGO RAS platform prove to be equivalent to those obtained with the Da Vinci Xi platform, it should lead to a progressive increase in the use of the HUGO RAS platform, resulting in a reduction in the overall costs associated with robotic urological surgery.

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugenio Brunocilla, Prof, MD; Phone Number: +39 051 2142374; Email: eugenio.brunocilla@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna
    • Contact: Eugenio Brunocilla; Phone Number: +39 051 2142374; Email: eugenio.brunocilla@unibo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients with Prostate Cancer (Group A)

• Age ≥ 18 years.
• Life expectancy greater than 10 years.
• Diagnosis of prostate cancer following prostate needle biopsy.
• Clinical stage cT1-T3b, N0-1 disease.
• Positive anesthetic fitness assessment for robot-assisted radical prostatectomy.
• Provision of informed consent for the study.

Patients with Kidney Cancer (Group B)

• Age ≥ 18 years.
• Radiological diagnosis of organ-confined kidney cancer at clinical stage T1a or T1b.
• Underwent CT and/or MRI of the abdomen with contrast medium.
• Positive anesthetic fitness assessment for robot-assisted partial nephrectomy.
• Provision of informed consent for the study.

Exclusion Criteria:

Patients with Prostate Cancer (Group A)

• Expression of a preference for radical treatment other than surgery (e.g., external radiotherapy).
• Metastatic prostate cancer (M1).
• Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Patients with Kidney Cancer (Group B)

• Indication for radical nephrectomy.
• Metastatic kidney cancer (M1).
• Other conditions deemed by healthcare professionals to contraindicate inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prostate cancer; Patients with prostate cancer (Group A), enrolled according to the inclusion criteria, are randomized to undergo radical prostatectomy (RP) using either the Da Vinci Xi platform (control group) or the HUGO™ RAS platform (study group).	Procedure: Radical prostatectomy; Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
Active Comparator: kidney cancer; patients with kidney cancer (Group B), enrolled according to the inclusion criteria, are randomized to undergo partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform.	Procedure: Partial nephrectomy; partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications	To demonstrate the equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications observed within 90 days post-surgery. This evaluation will be conducted separately for: Patients undergoing radical prostatectomy (RP). Patients undergoing partial nephrectomy (PN). perioperative complication rate of grade greater than or equal to Clavien-Dindo IIIa within 90 days after surgery will be calculated.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators		during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times		during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions	Instrument conflicts and malfunctions will be calculated (in number and %)	during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss		during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.		up to 4 days
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins		90 days after surgery
Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.		5 years
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time		5 years
Oncologic outcomes of PR or PN surgery : Overall survival		5 years
Oncologic outcomes of PR or PN surgery : Cancer-specific survival		5 years
functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function	The possible scores for the IIEF-5 range from 5 to 25, and erectile dysfunction is classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).	5 years
functional outcomes of PR or PN surgery: - Number of pads used		5 years

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Eugenio Brunocilla, Prof, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: February 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: URO ROBOT 2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No