Status:
RECRUITING
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Robotic-assisted radical prostatectomy (RALP) has become the standard of care in the management of localized prostate cancer. However, post-prostatectomy erectile dysfunction (ED) and urinary incontin...
Eligibility Criteria
Inclusion
- Age \> 18 years at the time of consent.
- Men who are potent (SHIM ≥ 17) and sexually active, who are planned to undergo a grade 1, 2, or 3 nerve-sparing approaches, as per the grading system during RALP.
- Ability to understand and the willingness to sign a written informed consent.
Exclusion
- Subjects who are candidates for salvage RALP
- Subjects on androgen deprivation therapy (ADT)
- Subjects in whom PDE5 inhibitors are contraindicated
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 14 2027
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06945315
Start Date
November 14 2023
End Date
July 14 2027
Last Update
April 25 2025
Active Locations (1)
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1
Mount Sinai Hospital
New York, New York, United States, 10029