Prostate Cancer (Adenocarcinoma), Renal Cancer
Conditions
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.
Interventions
PROCEDURERadical prostatectomy
Radical prostatectomy performed using the Da Vinci Xi and the HUGO RAS platform
PROCEDUREPartial nephrectomy
partial nephrectomy (PN) using either the Da Vinci Xi platform or the HUGO™ RAS platform
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of the HUGO RAS platform compared to the Da Vinci Xi robot in terms of perioperative complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | during surgery | Instrument conflicts and malfunctions will be calculated (in number and %) |
| 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 | — |
| Equivalence between surgeries performed using the Da Vinci Xi and the HUGO RAS platform: Ergonomics for the primary and secondary operators | during surgery | — |
| 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 | 5 years | 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). |
| functional outcomes of PR or PN surgery: - Number of pads used | 5 years | — |
| Oncologic outcomes of PR or PN surgery : Survival time free of biochemical recurrence of disease. | 5 years | — |
Countries
Italy
Contacts
Primary ContactEugenio Brunocilla, Prof, MD
Outcome results
None listed