3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy: The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted.
Then a radical prostatectomy is performed.
Study summary
This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.
Eligibility
Sex
MALE
Min age
40 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
1. Signature of the written informed consent and consent to the use of personal data
2. Age \> 40 years and male sex
3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
4. Disease with evidence of bulging or radiological T3 on pre-operative MRI
5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
6. Absence of bulky (\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy
8. ECOG PS 0-1
9. Life expectancy ≥ 5 years
10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \>17
11. Availability of the patient's pre-operative clinical data
12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection
Exclusion Criteria:
1. Special histotypes of prostate cancer
2. Patients with PSA \> 100 ng/ml at diagnosis
3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.
Primary outcome measure(s)
Perioperative surgical oncological outcomes — 12 months after surgery Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery
Trial sites (2)
Facility
City
Region
Status
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo
Turin
Recruiting
AOU san Luigi Gonzaga
Orbassano
Turin
Recruiting
More Fondazione del Piemonte per l'Oncologia trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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