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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Not yet enrolling

Conditions: Renal Cancer; Prostate Cancer (Adenocarcinoma)

Treatments: Procedure: Partial nephrectomy; Procedure: Radical prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06844513

URO ROBOT 2023

Details and patient eligibility

About

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).

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 2 patient groups

prostate cancer

Active Comparator group

Description:

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).

Treatment:

Procedure: Radical prostatectomy

kidney cancer

Active Comparator group

Description:

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.

Treatment:

Procedure: Partial nephrectomy