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NCT06059859
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy
NA trial testing Augmented reality robot-assited radical prostatectomy in Prostatic Neoplasm in 318 participants. Currently enrolling.
1 January 2026
Quick facts
| Lead sponsor | European Institute of Oncology |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 318 |
| Start date | 1 January 2022 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 January 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Augmented reality robot-assited radical prostatectomy
- Mixed reality intraoperative frozen section analysis
- Robot-assited radical prostatectomy
Conditions studied
- Prostatic Neoplasm — all drugs for Prostatic Neoplasm →
Sponsor
European Institute of Oncology
Who can join
Adults 18 to 70, male only, with Prostatic Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A Phase 3 Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins: A Clinical Trial Protocol.
Musi G, Mistretta FA, de Cobelli O, Bellin A, et al · · 2024 · cited 4× · PMID 38333626 · DOI 10.1016/j.euros.2024.01.006
Verify or expand the search:
- PubMed search for NCT06059859
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06059859 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by European Institute of Oncology
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06059859.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing