Clinical trial NCT06945315: SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
Official title: Robotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Prostate Cancer
Erectile Dysfunction
Keywords: Robotic-Assisted Laparoscopic Prostatectomy (RALP)
SAFE (Saline assisted fascial engorgement)
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 196
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
Secondary outcomes:
measure: The Erection Hardness Score (EHS)
timeFrame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Study Principal Investigator
name: Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)
role: PRINCIPAL_INVESTIGATOR
References: