Clinical trial · Interventional
Tractography-Guided Nerve-Sparing in Prostate Cancer
PRO-TRACT: Prostate Tractography for Optimized Nerve-Sparing - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Incontinence Following Surgical Procedure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate Tractography for Nerve-Sparing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with prostate cancer undergoing robot-assisted radical prostatectomy.
- description
- 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.
- interventionNames
- Procedure: Prostate Tractography for Nerve-Sparing
Primary outcomes (1)
- measure
- Evaluation of erectile function at 6-month.
- timeFrame
- From surgery (day 0) and at the 6-month follow-up (day 180).
- description
- Imaging versus Patient-Reported Outcome Measure (PROM).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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