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| Name | Class |
|---|---|
| San Luigi Gonzaga Hospital | OTHER |
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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.
Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).
Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D group | Experimental | in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle. A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed |
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| no3D group | Active Comparator | For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication. At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images. Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative surgical oncological outcomes | 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 | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Micturition outcomes | Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions. | 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Verify the potential application of AI | Verify the potential application of AI as an alert system during surgery in order to reduce the rate of possible intraoperative complications | 12 months after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enrico Checcucci, MD | Contact | +390119933632 | enrico.checcucci@ircc.it | |
| Marco Asioli | Contact | +390119933463 | marco.asioli@ircc.it |
| Name | Affiliation | Role |
|---|---|---|
| Enrico Checcucci, MD | Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo | Recruiting | Candiolo | Turin | 10060 | Italy |
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Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.
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| Sexual function outcomes |
Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire). |
| 5 years after surgery |
| Oncological outcomes | Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication | 5 years after surgery |
| AOU san Luigi Gonzaga | Recruiting | Orbassano | Turin | 10060 | Italy |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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