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Tractography-Guided Nerve-Sparing in Prostate Cancer

RecruitingNAAges 18 Years - anyMaleMassimo Valerio
NCT07847385 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ont

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📋 Eligibility rules (as published)
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
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What it tests

  • Prostate Tractography for Nerve-Sparing
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Where

1 site
Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie
Geneva, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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