Prostate Cancer (Adenocarcinoma)URO-ROBOT-2023NCT06844513
Comparison Between HUGO RAS Robotic Platform and Da Vinci Robotic Platform
A study testing Radical prostatectomy and Partial nephrectomy in people with Prostate Cancer (Adenocarcinoma) and Renal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Renal Cancer
- What is being tested?
- Radical prostatectomy and Partial nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 31 Mar 2025to 1 Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Eugenio Brunocilla, +39 051 2142374, eugenio.brunocilla@unibo.it
About this study
Official title: 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).
Read the 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.
- Conditions
- Prostate Cancer (Adenocarcinoma), Renal Cancer
- Being tested
- Radical prostatectomy, Partial nephrectomy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical prostatectomyProcedure or surgery
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
Partial nephrectomyProcedure or surgery
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform
| Study group | Role | What they receive |
|---|---|---|
| prostate cancer | Active comparator | 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). Receives: Procedure: Radical prostatectomy |
| kidney cancer | Active comparator | 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. Receives: Procedure: Partial nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (12)
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators
Measured: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times
Measured: 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 %)
Measured: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss
Measured: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.
Measured: up to 4 days
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins
Measured: 90 days after surgery
Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.
Measured: 5 years
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time
Measured: 5 years
Oncologic outcomes of PR or PN surgery : Overall survival
Measured: 5 years
Oncologic outcomes of PR or PN surgery : Cancer-specific survival
Measured: 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).
Measured: 5 years
functional outcomes of PR or PN surgery: - Number of pads used
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start31 Mar 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenio Brunocilla, Prof, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844513
- Sponsor's protocol ID
- URO ROBOT 2023
- Acronym
- URO-ROBOT-2023
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUGO RAS Robotic Platform for Radical Prostatectomy and Partial Nephrectomy: Comparison with the Da Vinci Robotic Platform
- ClinicalTrials.gov ID
- NCT06844513
- Acronym / sponsor ID
- URO-ROBOT-2023 / URO ROBOT 2023
- Conditions
- Prostate Cancer (Adenocarcinoma), Renal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Mar 2033 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prostate cancer | Active comparator | Procedure: Radical prostatectomyPatients 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). |
| kidney cancer | Active comparator | Procedure: Partial nephrectomypatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical prostatectomyRadical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform | Procedure or surgery | prostate cancer |
| Partial nephrectomypartial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform | Procedure or surgery | kidney cancer |
Primary outcome
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications
Time frame: 90 days
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.
12 secondary outcomes
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Operative times
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Instrument conflicts or malfunctions
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Intraoperative blood loss
Time frame: during surgery
Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Length of hospital stay.
Time frame: up to 4 days
Oncologic outcomes of PR or PN surgery - Rate of positive surgical margins
Time frame: 90 days after surgery
Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease.
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : - Metastasis-free survival time
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : Overall survival
Time frame: 5 years
Oncologic outcomes of PR or PN surgery : Cancer-specific survival
Time frame: 5 years
functional outcomes of PR or PN surgery: - International Index of Erectile Function (IIEF-5) score of recovery of sexual function
Time frame: 5 years
functional outcomes of PR or PN surgery: - Number of pads used
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugenio Brunocilla, Prof, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical prostatectomy and Partial nephrectomy in people with Prostate Cancer (Adenocarcinoma) and Renal Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eugenio Brunocilla, Prof, MD (+39 051 2142374, eugenio.brunocilla@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.