Nerve-sparing prostate surgery using micro-ultrasound guidance
Robotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
This study is testing a new approach to prostate surgery that uses advanced ultrasound technology to help men with localized prostate cancer keep their sexual function while effectively removing the cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06945315 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are sexually active men over 18 who are potent and scheduled for nerve-sparing prostate surgery.
Not a fit: Patients who are candidates for salvage surgery, on androgen deprivation therapy, or for whom PDE5 inhibitors are contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of erectile dysfunction and urinary incontinence in men undergoing prostate surgery.
How similar studies have performed: Previous studies have shown promising results with nerve-sparing techniques and hydrodissection, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.