NCT07847385 Tractography-Guided Nerve-Sparing in Prostate Cancer
| NCT ID | NCT07847385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massimo Valerio |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 23 participants in total. It began in 2026-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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.
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
Contact & Investigator
Massimo Valerio, Prof Dr med
PRINCIPAL INVESTIGATOR
HUG
Frequently Asked Questions
Who can join the NCT07847385 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07847385 currently recruiting?
Yes, NCT07847385 is actively recruiting participants. Contact the research team at vincent.benard@hug.ch for enrollment information.
Where is the NCT07847385 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT07847385 clinical trial?
NCT07847385 is sponsored by Massimo Valerio. The principal investigator is Massimo Valerio, Prof Dr med at HUG. The trial plans to enroll 23 participants.
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