Actively Recruiting
RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted Radical Prostatectomy versus no 3D Intervention in Prostate Cancer: A Prospective Multicenter Randomized Controlled Trial
Led by Fondazione del Piemonte per l'Oncologia · Updated on 2024-03-19
120
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
F
Fondazione del Piemonte per l'Oncologia
Lead Sponsor
S
San Luigi Gonzaga Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the impact of using Artificial Intelligence 3D Augmented Reality (AI 3D AR) during robot-assisted radical prostatectomy compared to surgery without 3D guidance in men with prostate cancer. The study aims to see if this technology can improve both cancer control and functional outcomes, such as urinary continence and sexual potency, especially for tumors invading the prostate capsule or seminal vesicles. This prospective randomized multicenter trial evaluates whether AI 3D AR reduces the risk of positive surgical margins and the need for additional treatments. Participants will undergo robot-assisted laparoscopic radical prostatectomy using the Da Vinci HD robotic system. In the 3D group, surgeons use AI software to project virtual 3D images of the prostate and tumor during surgery, guiding nerve-sparing techniques and targeted biopsies to check for cancer spread. The no-3D group will have surgery guided by conventional methods, including cognitive biopsies based on MRI. Both groups receive a reconstructive phase following total anatomical reconstruction techniques. During the study, participants will be monitored for surgical and cancer outcomes at 12 months after surgery, with longer-term assessments of urinary function, sexual function, and oncological results over five years. Follow-up visits will collect clinical data and evaluate the benefits and risks of using AI 3D AR. The study includes men aged 40 to 99 years with specific prostate cancer characteristics confirmed by MRI and biopsy.
CONDITIONS
Brief Title
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and consent to use personal data
- Male, aged over 40 years
- Pre-operative MRI done following ESUR recommendations with PiRads V.2 reporting
- Evidence of bulging or radiological T3 stage on pre-operative MRI
- Histological diagnosis of acinar type prostate cancer in MRI-highlighted area
- No bulky (>3 cm), bony, visceral, retroperitoneal or pelvic lymph node metastases
- Eligible for radical prostatectomy plus pelvic lymphadenectomy
- ECOG performance status 0-1
- Life expectancy of at least 5 years
- Motivated to preserve erection with pre-operative sexual activity and IIEF score over 17
- Availability of pre-operative clinical data
- Willingness to attend all follow-up visits and consent to data collection
You will not qualify if you...
- Special histological types of prostate cancer
- PSA level over 100 ng/ml at diagnosis
- Inability to undergo MRI or MRI of insufficient quality for 3D reconstruction
- Receiving other antineoplastic treatments including investigational endocrine therapies
- Serious uncontrolled medical conditions or active infections
- Dementia or psychiatric illness limiting compliance or informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants undergo robot-assisted radical prostatectomy with or without AI 3D augmented reality guidance, followed by immediate recovery from surgery.
1 surgical visit and immediate post-operative hospital stay
Duration - Up to 5 years
Participants are monitored for surgical outcomes, including functional and oncological results, with assessments continuing for up to 5 years after surgery.
Regular follow-up visits over 5 years
Trial Site Locations
Total: 2 locations
1
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, Italy, 10060
Actively Recruiting
2
AOU san Luigi Gonzaga
Orbassano, Turin, Italy, 10060
Actively Recruiting
Research Team
E
Enrico Checcucci, MD
M
Marco Asioli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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