SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Phase 3

Recruiting

• Conditions: Prostate Cancer; Erectile Dysfunction
• Interventions: Procedure: RALP (Robotic-assisted radical prostatectomy); Drug: SAFE (Saline assisted fascial engorgement)

• Registration Number: NCT06945315
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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 incontinence still pose a challenge that adversely affects the patient's quality of life. Hydrodissection (HD) was introduced in 1987 in the medical field and it was tested for the first time during a retropubic radical prostatectomy back in 2005. Since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of neuropraxia. In an effort to achieve a balance between oncological excision and functional preservation, prostate surgery is evolving to incorporate intraoperative real-time evaluation of extracapsular extension. Recently, a micro-ultrasound operating at 29 MHz has been introduced. It provides a resolution down to 70 μ to assess the glandular pattern and cellular density of the prostatic tissue. Given the experience in more than a thousand cases with this technology, and the growing literature showing promising results in the detection and staging of prostate cancer; the researchers decided to implement this tool as guidance for hydrodissection of the layers of the lateral prostatic fascia.

Robotic-Assisted Laparoscopic Prostatectomy and SAFE (Saline assisted fascial engorgement) nerve preservation guided by Microultrasound (MUS) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (HD) on erectile function outcomes after RALP. This innovative approach consists of a transrectal ultrasound-guided HD using a high-resolution Microultrasound (MUS) (ExactVu micro-ultrasound, Exact Imaging, Markham, Canada). The technique will be applied to those patients who undergo grade 1, 2, or 3 NS approach taking into account the grading system proposed by Tewari et al.

The hypothesis is that the SAFE technique could minimize the risk of a traumatic neurovascular bundle dissection while assessing the prostatic capsule integrity with a high-resolution MUS. The researchers also hypothesize that the use of SAFE along with RALP will optimize the post-surgery recovery of erectile function.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-14
• Status Verified: 2025-04
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-07-14
• Study Completion: 2027-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RALP with SAFE Technique	RALP (Robotic-assisted radical prostatectomy)	Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement).
RALP with SAFE Technique	SAFE (Saline assisted fascial engorgement)	Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement).
RALP without SAFE Technique	RALP (Robotic-assisted radical prostatectomy)	Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) without SAFE (Saline assisted fascial engorgement).

Primary Outcome Measures

Name	Time	Method
Sexual Health Inventory for Men (SHIM)	Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery	The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.

Secondary Outcome Measures

Name	Time	Method
The Erection Hardness Score (EHS)	Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery	The Erection Hardness Score (EHS) is tool used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection. Higher score indicates better health outcomes.

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States