SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

NCT06945315 | Recruiting Phase 3 DMC

• 1 other identifier: STUDY-22-01522
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sexual Health Inventory for Men (SHIM)

  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.

  Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery

Secondary Outcomes (1)

• The Erection Hardness Score (EHS)

  Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery

Study Arms (2)

RALP with SAFE Technique

EXPERIMENTAL

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

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

RALP without SAFE Technique

ACTIVE COMPARATOR

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

Procedure: RALP (Robotic-assisted radical prostatectomy)

Interventions

RALP (Robotic-assisted radical prostatectomy) PROCEDURE

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.

RALP with SAFE Technique; RALP without SAFE Technique

SAFE (Saline assisted fascial engorgement) DRUG

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.

RALP with SAFE Technique

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since this is a prostate cancer study, only male candidates are eligible for the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subjects who are candidates for salvage RALP
• Subjects on androgen deprivation therapy (ADT)
• Subjects in whom PDE5 inhibitors are contraindicated

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraja Tillu

CONTACT

(332) 256-8528; Neeraja.tillu@mountsinai.org

Monali Fatterpekar, PhD

CONTACT

(212) 241-0751; monali.fatterpekar@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors (physician associate/physician assistant or Nurse practitioner) will be blinded from the study arm allocated. While investigators cannot be blinded due to the nature of the intervention, implementation of allocation concealment will minimize the chance of potential allocation biases.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and System Chair, Milton and Carroll Petrie Department of Urology. Director of Center of Excellence for Prostate Cancer at the Tisch Cancer Institute

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: November 14, 2023
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): July 14, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. Any purpose. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in ISMMS data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).

Locations

US (1)