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Search / Trial NCT06059859

Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Sep 22, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of augmented reality (AR) technology during robot-assisted surgery for prostate cancer. The goal is to see if this advanced technology can help surgeons more accurately preserve important nerves during the procedure, which could lead to better recovery of erectile function and lower rates of cancer returning after surgery. Researchers hope that using AR will result in fewer positive surgical margins, meaning the cancer is less likely to remain after the operation.

To participate in this trial, men aged 18 and older with untreated, biopsy-proven prostate cancer may be eligible if they have low to intermediate risk based on specific medical criteria. Participants will receive detailed information about the trial and must provide written consent. If selected, they can expect to undergo the AR-assisted surgery and will be monitored for their recovery and any side effects. This trial is currently recruiting participants, and it's an important step in validating the use of augmented reality in prostate cancer surgery.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Untreated, biopsy-proven adenocarcinoma of the prostate Age ≥18 years
  • European Association of Urology (EAU) low or intermediate risk prostate cancer:
  • PSA≤20 ng/ml
  • cT≤2b
  • International Society for Urological Pathology \[ISUP\] grade group≤III Written informed consent provided for participation in the trial International Index of Erectile Function-5 (IIEF-5)≥20 No contraindications for multiparametric magnetic resonance imaging (mpMRI)
  • Exclusion Criteria:
  • Any prior therapy for prostate cancer
  • European Association of Urology (EAU) high risk prostate cancer:
  • PSA\>20 ng/ml or
  • cT\>2b or
  • ISUP grade group\>III International Index of Erectile Function-5 (IIEF-5)\<20 Prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components Morbidity that would limit compliance with study protocols Controindications to perform mpMRI

About European Institute Of Oncology

The European Institute of Oncology (IEO) is a leading research and treatment center based in Milan, Italy, dedicated to advancing cancer care through innovative clinical research and personalized medicine. Renowned for its commitment to multidisciplinary approaches, IEO integrates cutting-edge research with clinical practice to improve patient outcomes. The institute actively sponsors and conducts clinical trials across various cancer types, fostering collaboration between oncologists, researchers, and industry partners. With a focus on translating scientific discoveries into effective therapies, IEO plays a pivotal role in the global fight against cancer, contributing to the development of new treatment protocols and enhancing the understanding of oncological diseases.

Locations

Milan, , Italy

Patients applied

0 patients applied

Trial Officials

Ottavio de Cobelli, MD; PhD

Principal Investigator

European Institute of Oncology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported