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NCT07847385Recruiting

Tractography-Guided Nerve-Sparing in Prostate Cancer

Summary

Radical prostatectomy (RP) is an effective treatment leading to a high rate of oncological control. However, despite advances in robot-assisted RP, the genito-urinary function, especially erectile function and urinary continence, may be significantly impaired after surgery. Our study aims to characterize and map the nerve fibers surrounding the prostate before and after surgery using diffusion tensor magnetic resonance imaging (DTI), a non-invasive magnetic resonance imaging (MRI) technique. This relatively new technology, combined with the 3D tractography software, will allow us to create a personalized 3D model of the periprostatic nerves. This virtual model will help us to assess the nerve bundles and how the surgery impacts their integrity. DTI and 3D reconstruction will be performed before and 6 months after surgery. The pre-surgery 3D virtual model will be overlaid and mapped onto the intraoperative surgical view, providing the surgeon with a visual guide of the nerve fiber organization. At the post-surgery level, the 3D virtual model of the nerve bundles will be compared to the pre-surgery model. Post-treatment changes at 6 months may help assess nerve preservation and their relationship with erectile (dys)function. The main questions the clinical study aims to answer are: 1. Post-treatment DTI-Tractography parameter changes at 6 months may help assess nerve recovery and their relationship with erectile (dys)function (PROMs - IIEF-5 score) 2. Post-treatment DTI-Tractography parameter changes at 6 months may help assess their relationship with urinary function 3. At the post-surgery level, the 3D virtual model of the nerve bundles will be compared to the pre-surgery 3D model. 4. The pre-surgery 3D virtual model will be overlaid and mapped onto the intraoperative surgical view, providing the surgeon with a visual guide of the nerve fiber organization (mean surgery time, surgeon feedback assessment, etc., will be evaluated.) Tumor location based on the 3D model will also be explored.

Inclusion criteria

• Histological confirmed diagnosis of prostate cancer (PCa) based on prostate biopsy • Multidisciplinary indication for radical prostatectomy, validated by the Urology Tumor Board • No prior treatment of prostate cancer • Capacity to provide informed consent

Exclusion criteria

• Unwillingness to participate. • Pre-existing impaired sexual function before surgery (IIEF5 Score of ≤21) • Diagnosis of neuropathy • Inability to comply with study procedure (e.g. due to language barriers, psychological disorders, dementia, anxiety/claustrophobia during pelvic MRI etc.) or medical contraindications to MRI

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland
Sponsor
Massimo Valerio(Other)
Protocol no.
2025-01992
Conditions
Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence Following Surgical Procedure
Interventions
Procedure

Treatments studied

  • Prostate Tractography for Nerve-Sparing

Collaborators

University of Geneva, Switzerland

Locations · 1

  • Geneva, SwitzerlandHôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'UrologieRecruiting at this site

In total, worldwide, the only site listed in the registry is recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: September 29, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2025 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.