SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Mount Sinai Health System

Status and phase: Enrolling; Phase 3

Conditions: Erectile Dysfunction; Prostate Cancer

Treatments: Procedure: RALP (Robotic-assisted radical prostatectomy); Drug: SAFE (Saline assisted fascial engorgement)

Study type: Interventional

Funder types: Other

Identifiers

NCT06945315

STUDY-22-01522

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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196 participants in 2 patient groups

RALP with SAFE Technique

Experimental group

Description:

Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement).

Treatment:

Drug: SAFE (Saline assisted fascial engorgement)

Procedure: RALP (Robotic-assisted radical prostatectomy)

RALP without SAFE Technique

Active Comparator group

Description:

Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) without SAFE (Saline assisted fascial engorgement).

Treatment:

Procedure: RALP (Robotic-assisted radical prostatectomy)