NCT06318559Recruiting
Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 15 Feb 2024
- Start date
- 29 Jun 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Diseases
- Prostate cancer
- NCT number
- NCT06318559
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 29 Jun 2022 to the primary completion date, 31 Dec 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
- Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to 99 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione del Piemonte per l'Oncologia IRCCS Candiolo Coordinator of this site? Confirm its status | Candiolo | Italy | Recruiting |
| Aou San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.