Tractography-Guided Nerve-Sparing in Prostate Cancer
PRO-TRACT: Prostate Tractography for Optimized Nerve-Sparing - A Pilot Study
- Prostate Cancer
- Erectile Dysfunction Following Radical Prostatectomy
- Urinary Incontinence Following Surgical Procedure
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Massimo Valerio
- Enrolment target
- 23
- Started
- 1 September 2026
- Main results due
- 31 December 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Men only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
Geneva, Canton of Geneva, Switzerland
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07847385. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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