Actively Recruiting

Phase Not Applicable
Age: 40Years - 99Years
MALE
NCT06318559

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

Led by Fondazione del Piemonte per l'Oncologia · Updated on 2024-03-19

120

Participants Needed

2

Research Sites

287 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 99Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

E

Enrico Checcucci, MD

CONTACT

M

Marco Asioli

CONTACT

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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