Clinical trial NCT06844513: Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform
Official title: HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer (Adenocarcinoma)
Renal Cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
timeFrame: 90 days
Secondary outcomes:
measure: Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators
timeFrame: during surgery
measure: Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times
timeFrame: during surgery
measure: Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions
timeFrame: during surgery
measure: Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss
timeFrame: during surgery
measure: Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.
timeFrame: up to 4 days
measure: Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins
timeFrame: 90 days after surgery
measure: Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.
timeFrame: 5 years
measure: Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time
timeFrame: 5 years
measure: Oncologic outcomes of PR or PN surgery : Overall survival
timeFrame: 5 years
measure: Oncologic outcomes of PR or PN surgery : Cancer-specific survival
timeFrame: 5 years
measure: functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function
timeFrame: 5 years
measure: functional outcomes of PR or PN surgery: - Number of pads used
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Eugenio Brunocilla, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: