Prostate CancerPhase 3NCT06945315
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
A Phase 3 study testing RALP (Robotic-assisted radical prostatectomy) and SAFE (Saline assisted fascial engorgement) in people with Prostate Cancer and Erectile Dysfunction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- RALP (Robotic-assisted radical prostatectomy) and SAFE (Saline assisted fascial engorgement)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 14 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects who are candidates for salvage RALP
- Subjects on androgen deprivation therapy (ADT)
- Subjects in whom PDE5 inhibitors are contraindicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Manish Choudhary, MBBS MCh, 929-659-0229, manish.choudhary@mountsinai.org
Monali Fatterpekar, PhD, 212-241-0751, monali.fatterpekar@mountsinai.org
About this study
Official title: Robotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
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
- Being tested
- RALP (Robotic-assisted radical prostatectomy), SAFE (Saline assisted fascial engorgement)
- Keywords
- Robotic-Assisted Laparoscopic Prostatectomy (RALP), SAFE (Saline assisted fascial engorgement)
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RALP (Robotic-assisted radical prostatectomy)Procedure or surgery
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)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.
| Study group | Role | What they receive |
|---|---|---|
| RALP with SAFE Technique | Experimental | Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement). Receives: 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). Receives: Procedure: RALP (Robotic-assisted radical prostatectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
Secondary outcomes (1)
The Erection Hardness Score (EHS)
The Erection Hardness Score (EHS) is tool used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection. Higher score indicates better health outcomes.
Measured: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start14 Nov 2023
- Primary completion14 Jul 2027 (estimated)
- Study completion14 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashutosh Kumar Tewari, Icahn School of Medicine at Mount Sinai
- Investigators
- Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.), Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945315
- Sponsor's protocol ID
- STUDY-22-01522
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Laparoscopic Prostatectomy (RALP) and SAFE (Saline Assisted Fascial Engorgement) Nerve Preservation Guided by Micro-ultrasound: A Phase III RCT
- ClinicalTrials.gov ID
- NCT06945315
- Acronym / sponsor ID
- STUDY-22-01522
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- Robotic-Assisted Laparoscopic Prostatectomy (RALP), SAFE (Saline assisted fascial engorgement)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 14 Jul 2027 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RALP with SAFE Technique | Experimental | Procedure: RALP (Robotic-assisted radical prostatectomy), Drug: SAFE (Saline assisted fascial engorgement)Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) + SAFE (Saline assisted fascial engorgement). |
| RALP without SAFE Technique | Active comparator | Procedure: RALP (Robotic-assisted radical prostatectomy)Erectile function recovery will be evaluated for patients receiving Robotic-Assisted Laparoscopic Prostatectomy (RALP) without SAFE (Saline assisted fascial engorgement). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Subjects who are candidates for salvage RALP
- Subjects on androgen deprivation therapy (ADT)
- Subjects in whom PDE5 inhibitors are contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | RALP with SAFE Technique, RALP without SAFE Technique |
| 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. | Drug | RALP with SAFE Technique |
Primary outcome
Sexual Health Inventory for Men (SHIM)
Time frame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
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.
1 secondary outcome
The Erection Hardness Score (EHS)
Time frame: Baseline (Week 0), 6 weeks, 3-months, 6-months, 12-months and 24-months following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashutosh Kumar Tewari, MBBS, MCh, FRCS (Hon.) principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RALP (Robotic-assisted radical prostatectomy) and SAFE (Saline assisted fascial engorgement) in people with Prostate Cancer and Erectile Dysfunction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neeraja Tillu ((332) 256-8528, Neeraja.tillu@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.