Nerve-sparing prostate surgery using micro-ultrasound guidance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of robotic-assisted radical prostatectomy (RALP) combined with saline-assisted fascial engorgement (SAFE) to improve outcomes for men with localized prostate cancer. The study utilizes advanced micro-ultrasound technology to enhance nerve-sparing techniques during surgery, potentially reducing the risk of erectile dysfunction and urinary incontinence post-operation. Participants will be men over 18 who are sexually active and planned for nerve-sparing surgery. The trial aims to balance effective cancer removal with the preservation of sexual function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* Subjects who are candidates for salvage RALP
* Subjects on androgen deprivation therapy (ADT)
* Subjects in whom PDE5 inhibitors are contraindicated

Where it's running

• Mount Sinai Hospital
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.) — Study Principal Investigator
• Study coordinator: Neeraja Tillu
• Email: Neeraja.tillu@mountsinai.org
• Phone: (332) 256-8528

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.