Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

Cancer of Prostate Clinical Trial

— RIDERS  

Official title:

RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06318559
• Other study ID #: 027-FPO22
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Enrico Checcucci, MD
• Phone: +390119933632
• Email: enrico.checcucci[@]ircc.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Prostate
• Prostatic Neoplasms

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo	Candiolo	Turin
Italy	AOU san Luigi Gonzaga	Orbassano	Turin

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia	San Luigi Gonzaga Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	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
Secondary	Sexual function outcomes	Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).	5 years after surgery
Secondary	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