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Prostate CancerCOMPAR-PNCT05766163

Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Prostate

A study testing DaVinci RARP, Hugo RARP and Versius RARP in people with Prostate Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms: DaVinci; Hugo; Versius. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
DaVinci RARP, Hugo RARP and Versius RARP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteItaly
Study dates
14 Mar 2023to Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 18 and < 90 years;
  • Organ-localized prostate cancer with a surgical indication of radical prostatectomy;
  • Informed consent provided.

Who cannot join

  • Age < 18 and > 90 years;
  • Contraindication to radical prostatectomy procedure;
  • Non-organ confined prostate cancer;
  • Refusal to participate.

Trial locations and contacts

1 site in 1 country.

Alessandro AA Antonelli contact

+39 0458127701

alessandro.antonelli@aovr.veneto.it

Italy1 site, 1 recruiting

  • Urology Unit, AOUI Verona

    Verona, 37126

    Alessandro AA Antonelli, +39 0458127701, alessandro.antonelli@aovr.veneto.it

    Unità di Ricerca Clinica, +39 0458122844, unita.ricerca.clinica@aovr.veneto.it

    Recruiting

Other trials in Italy

About this study

Official title: Comparative Evaluation of New Surgical Robotic Platforms for the Radical Prostatectomy Procedure

The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms:

  • DaVinci;
  • Hugo;
  • Versius.

The questions it aims to answer are:

  • Does the estimation of the post-operative complications suggest something?
  • Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?

Participants will be invited to fill out questionnaires and join one of these three groups:

  1. surgery with the daVinci platform;
  2. surgery with the Hugo platform;
  3. surgery with the Versius platform.
Conditions
Prostate Cancer
Being tested
DaVinci RARP, Hugo RARP, Versius RARP
Keywords
Robotic-assisted surgery, Prostatectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes
Medical subject headings
Prostatic Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DaVinci RARPDevice

    Also called DaVinci® Surgical System

    Assisted-robotic radical prostatectomy.

  • Hugo RARPDevice

    Also called Hugo™ RAS System

    Assisted-robotic radical prostatectomy.

  • Versius RARPDevice

    Also called Versius® Robotic Surgery System

    Assisted-robotic radical prostatectomy.

Study groups in NCT05766163
Study groupRoleWhat they receive
DaVinci systemActive comparatorRobot-assisted radical prostatectomy is carried out through daVinci platform.
Receives: Device: DaVinci RARP
Hugo systemExperimentalRobot-assisted radical prostatectomy is carried out through Hugo platform.
Receives: Device: Hugo RARP
Versius systemExperimentalRobot-assisted radical prostatectomy is carried out through Versius platform.
Receives: Device: Versius RARP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with postoperative complications

    Overall postoperative complications (% score >0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Measured: Over the 4 days post surgery

  2. Number of participants with moderate to major postoperative complications

    Moderate to major complications (% score >=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Measured: Over the 4 days post surgery

  3. Number of participants with major postoperative complications

    Major complications (% score >=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication

    Measured: Over the 4 days post surgery

Secondary outcomes (14)

  1. Estimated Blood Loss

    Volume

    Measured: Intraoperative

  2. Overall duration of the surgery

    Minutes

    Measured: Intraoperative

  3. Anesthesia, Lymphadenectomy, Prostatectomy

    Minutes

    Measured: Entrance of patient into operating room until completion of surgery

  4. Number and type of intraoperative complications

    Note

    Measured: Intraoperative

  5. Postoperative hospitalization

    Days of recovery until the date of release

    Measured: From the surgery day up to 10 days postoperative

  6. Postoperative pain

    Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Measured: 1-4 days postoperative

  7. Prostate Specific Antigen (PSA)

    PSA test

    Measured: 1 month follow-up

  8. Positive Surgical Margin

    Rate at histological examination

    Measured: Up to 2 weeks postoperative (during histological analysis)

  9. Lymph nodes resection

    Number of lymph nodes removed

    Measured: Intraoperative

  10. Urinary, sexual, and intestinal function assessment

    University of California, Los Angeles (UCLA) Prostate Cancer Index (PCI) questionnaire

    Domains:

    • Urinary function (5 items)
    • Urinary bother (1 item)
    • Sexual function (8 items)
    • Sexual bother (1 item)
    • Bowel function (4 items)
    • Bowel bother (1 item)

    Response options: 3- to 6-point Likert scales. The higher the score, the better the outcome

    Measured: Preoperative and follow-up (1, 3 and 6 months)

  11. Quality of Life Evaluation

    Short Form Health Survey (SF-36) 36 questions (8 domains) for self-reported measure of health. Domain score from 0 to 100: the higher the score, the more favorable the state of health

    Measured: Preoperative and follow-up at 1, 3 and 6 months

  12. Time taken for platform-related technical steps

    Set up of operating table, Electric connections, Draping, Undraping, Docking, Undocking, Cleaning: time in minutes

    Measured: From the room setting, through surgical procedure until postoperative room restoration for each of expected 150 surgeries (through study completion: an average of 1 year)

  13. Possible malfunction of the platform

    Note

    Measured: Intraoperative

  14. Procedure-related costs

    Estimate

    Measured: From surgical procedure to the end of follow-up period (6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2023
  2. Study start14 Mar 2023
  3. Primary completionMar 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05766163
Sponsor's protocol ID
COMPAR-P
Acronym
COMPAR-P
Status last verified
Apr 2023
First submitted
13 Feb 2023
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Antonelli A, Veccia A, Malandra S, De Marco V, Rizzetto R, Gozzo A, Bianchi A, Brunelli M, Noale M, Cerruto MA, Bertolo R; University of Verona Residency Program in Urology. Six-month outcomes of a three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. versius robotic radical prostatectomy: (the COMPAR-P trial). J Robot Surg. 2026 Mar 19;20(1):361. doi: 10.1007/s11701-026-03260-5.

    PubMed 41851411

Questions about this trial

What is this clinical trial studying?

A study testing DaVinci RARP, Hugo RARP and Versius RARP in people with Prostate Cancer, run by Azienda Ospedaliera Universitaria Integrata Verona 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Alessandro AA Antonelli (+39 0458127701, alessandro.antonelli@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with postoperative complications (time frame: Over the 4 days post surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05766163, which also lists 1 linked publication.

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 12 Apr 2023.

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