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

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About this study

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.

Condition
Cancer of Prostate
Tested
3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
Sponsor
Fondazione del Piemonte per l'Oncologia

Who can join

Age
40 to 99 years
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 40 years
  • Maximum age: 99 years
  • Eligible sex: Male
  • Study condition: Cancer of Prostate
  • Signature of the written informed consent and consent to the use of personal data
  • Age \> 40 years and male sex
  • Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
  • Disease with evidence of bulging or radiological T3 on pre-operative MRI
  • Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
  • Absence of bulky (\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
  • Patients eligible for radical prostatectomy + pelvic lymphadenectomy
  • ECOG PS 0-1
  • Life expectancy ≥ 5 years
  • Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \>17
  • Availability of the patient's pre-operative clinical data
  • Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection

Exclusion 6

  • Special histotypes of prostate cancer
  • Patients with PSA \> 100 ng/ml at diagnosis
  • Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
  • Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
  • Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
  • Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.

Where

2 sites, 2 recruiting

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, Italy

Recruiting

AOU san Luigi Gonzaga

Orbassano, Turin, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.