Clinical trial · Interventional
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
NCT06318559CI-TRIAL-00075187RIDERSrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Prostate | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D group
- description
- 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
- interventionNames
- Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
- type
- ACTIVE_COMPARATOR
- label
- no3D group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.