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Taking people in ItalyNo phase

Tests 3D augmented reality guidance during robot-assisted prostate removal

Compares robot-guided prostate removal with and without 3D augmented reality, in men with prostate cancer.

Key facts

Who runs it
Fondazione del Piemonte per l'Oncologia
Where
Candiolo and Orbassano, ItalySee the 2 sites
Trial code
Registry title
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
Status
Recruiting
People taking part
120 people, planned
Started
29 Jun 2022
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
Record updated
19 March 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men with prostate cancer that bulges or looks like T3 on MRI, who are going to have robot-assisted radical prostatectomy and want to keep erections.

Age
Older than 40 years (up to 99 years).
Sex
Men only.
Disease stage
Acinar prostate cancer with bulging or radiological T3 disease on MRI. No bulky (>3 cm (1.2 in)), bone or organ lymph node spread in the pelvis or behind the abdomen.
Earlier treatment
No other anti-cancer drugs at the same time, including investigational hormone therapies.
Biomarker or test result
PSA must not be above 100 ng/ml at diagnosis.

Main reasons for not taking part

  • Special types of prostate cancer
  • PSA above 100 ng/ml at diagnosis
  • Cannot have an MRI or the MRI quality is too poor
  • Serious uncontrolled illness, including active infection
  • Dementia or psychiatric illness that limits taking part or giving consent

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
  • Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
  • Special histotypes of prostate cancer
  • Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 99 years old?

Where in Italy

  • Fondazione del Piemonte per l'Oncologia IRCCS CandioloCandiolo, ItalyContact: Enrico Checcucci, MDTaking people
  • Aou San Luigi GonzagaOrbassano, ItalyContact: Francesco Porpiglia, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 3D groupTreatment being tested

    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

    Treatment: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

  • no3D groupExisting treatment, for comparison

    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.

    Treatment: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
Plain-language title
Tests 3D augmented reality guidance during robot-assisted prostate removalGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06318559, who can take part
Record updated
19 March 2024