Tractography-Guided Nerve-Sparing in Prostate Cancer

NCT07847385 | Recruiting

• 2 other identifiers: 2025-019922025
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Post-treatment DTI-Tractography parameter changes at 6 months may help assess their relationship with urinary function
3. 3.At the post-surgery level, the 3D virtual model of the nerve bundles will be compared to the pre-surgery 3D model.
4. 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.

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Urinary Incontinence Following Surgical Procedure

Keywords

Prostate cancer; Robot-assisted Prostatectomy; Erectile dysfunction; Nerve-sparing; Diffusion tensor imaging; Tractography; Augmented reality; 3D virtual model of nerve fibers for surgical guidance; Low-risk prostate cancer; Intermediate-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of erectile function at 6-month.

  Imaging versus Patient-Reported Outcome Measure (PROM).

  From surgery (day 0) and at the 6-month follow-up (day 180).

Secondary Outcomes (3)

• 1. Evaluation of urinary function at 6 month follow-up.

  From surgery (day 0) and at the 6-month follow-up (day 180).

• Assessment of the feasibility of augmented reality using tractography-based 3D model.

  At surgery (day 0)

• 3. Concordance of pre- and postoperative Diffusion Tensor Imaging.

  At the end of the 6-month follow-up (day 180)

Study Arms (1)

Participants with prostate cancer undergoing robot-assisted radical prostatectomy.

EXPERIMENTAL

3 visits are related to the research protocol 1. Informed consent (Day - 30) 2. Preoperative MRI (DTI acquisition) and preoperative PROMs (day -14) 3. Postoperative MRI (DTI acquisition) and postoperative PROMs (day +180) The tractography will be performed according to established best practices. Robot-assisted PR (Day 0) is performed according to standard practice and is not part of the research-specific procedure.

Procedure: Prostate Tractography for Nerve-Sparing

Interventions

Prostate Tractography for Nerve-Sparing PROCEDURE

Tractography will be performed according to established best practices. To create the 3DVM, a high-performance workstation equipped with a high-end GPU will be used. ROI placement for nerve tractography and segmentation tasks will be performed semi-automatically using a previously trained nnU-Net pipeline. All inference will be strictly performed locally on this dedicated machine resulting in 4 segment masks (Prostate, Urethra, Index Lesion, Seminal Vesicles) that will be manually reviewed and corrected. The subsequent reconstructed Tractography bundles will be added to create the 3DTVM. The 3DTV model will be overlaid and mapped onto the intraoperative surgical view, providing the surgeon with a visual guide of the nerve fiber organizations (mean surgery time, surgeon feedback etc will be evaluated.)

Participants with prostate cancer undergoing robot-assisted radical prostatectomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massimo Valerio: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Massimo Valerio, Prof Dr med

  HUG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Benard, Resident

CONTACT

+ 41 79 553 62 68; vincent.benard@hug.ch

Laurence Zulianello, PhD

CONTACT

+ 41 22 372 79 70; laurence.zulianello@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Dr med

Model Details: Prospective exploratory pilot study

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 29, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)