NCT06318559 Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
| NCT ID | NCT06318559 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione del Piemonte per l'Oncologia |
| Condition | Cancer of Prostate |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-06-29 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-06-29 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Contact & Investigator
Enrico Checcucci, MD
PRINCIPAL INVESTIGATOR
Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Frequently Asked Questions
Who can join the NCT06318559 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 99 Years, studying Cancer of Prostate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06318559 currently recruiting?
Yes, NCT06318559 is actively recruiting participants. Contact the research team at enrico.checcucci@ircc.it for enrollment information.
Where is the NCT06318559 trial being conducted?
This trial is being conducted at Candiolo, Italy, Orbassano, Italy.
Who is sponsoring the NCT06318559 clinical trial?
NCT06318559 is sponsored by Fondazione del Piemonte per l'Oncologia. The principal investigator is Enrico Checcucci, MD at Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo. The trial plans to enroll 120 participants.
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