Recruiting
Phase 3

SAFE Nerve Sparing

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06945315

Conditions

Prostate Cancer

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RALP (Robotic-assisted radical prostatectomy)

SAFE (Saline assisted fascial engorgement)

Study Details

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.

Conditions

Prostate Cancer

Erectile Dysfunction

Study ID

NCT06945315

Start date

Nov 14, 2023

Status verified date

Apr, 2025

Completion date

Jul 14, 2027

Anticipated

Primary completion date

Jul 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

196 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: RALP with SAFE Technique

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

active comparator: RALP without SAFE Technique

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

Interventions

RALP (Robotic-assisted radical prostatectomy)

Robotic-assisted radical prostatectomy (RALP) is a standard surgical procedure for managing localized prostate cancer that focuses on prostate anatomy and surrounding structures to enable personalized surgeries. The procedure incorporates nerve-sparing techniques through careful dissection of the neurovascular bundle and can use a thermal and traction-free dissection to improve functional outcomes, particularly erectile function.

SAFE (Saline assisted fascial engorgement)

SAFE (Saline assisted fascial engorgement) an innovative technique to achieve enhanced nerve-sparing outcomes among patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Essentially a new method of hydro dissection, SAFE involves an injection of 30 cc of normal saline solution between the layers of the periprostatic fascia after early release of the neurovascular bundle. This injection effectively pushes the nerves away from the prostate, enabling a dissection of the prostate that is atraumatic vis a vis the neural hammock.

Primary outcome measure

  • Sexual Health Inventory for Men (SHIM) [ Time Frame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery ]

Central Contacts and Locations

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Ashutosh Tewari

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 25, 2025

Last verified

Apr, 2025

Keywords

  • Robotic-Assisted Laparoscopic Prostatectomy (RALP)
  • SAFE (Saline assisted fascial engorgement)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.