NCT06945315 SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
| NCT ID | NCT06945315 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2023-11-14 |
| Primary Completion | 2027-07-14 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 196 participants in total. It began in 2023-11-14 with a primary completion date of 2027-07-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.)
PRINCIPAL INVESTIGATOR
Study Principal Investigator
Frequently Asked Questions
Who can join the NCT06945315 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06945315 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 196 participants.
Is NCT06945315 currently recruiting?
Yes, NCT06945315 is actively recruiting participants. Contact the research team at Neeraja.tillu@mountsinai.org for enrollment information.
Where is the NCT06945315 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06945315 clinical trial?
NCT06945315 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.) at Study Principal Investigator. The trial plans to enroll 196 participants.
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