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Tractography-Guided Nerve-Sparing in Prostate Cancer

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About this study

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.

Condition
Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence Following Surgical Procedure
Tested
Prostate Tractography for Nerve-Sparing
Sponsor
Massimo Valerio

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence Following Surgical Procedure
  • 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 4

  • 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

Where

1 site, 1 recruiting

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

Geneva, Canton of Geneva, Switzerland

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.