Prostate Cancer study: SAFE
Official title SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)
ClinicalTrials.gov ID: NCT06945315
What this study is testing
What is SAFE (Saline assisted fascial engorgement)?
an investigational technique being studied to improve nerve‑sparing outcomes during robot‑assisted laparoscopic radical prostatectomy for prostate cancer is designed to use a saline injection to hydro‑dissect and push the neurovascular bundle away from the prostate during surgery
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The trial wants to see if using a high‑resolution micro‑ultrasound to guide saline injection during prostate removal reduces nerve damage and improves erectile function after surgery.
- Who it's for
- Men with localized prostate cancer who are scheduled for robotic‑assisted prostatectomy.
- What's involved
- Participants will have their surgery with or without the saline hydrodissection guided by micro‑ultrasound. They will attend pre‑operative visits, the surgery itself, and post‑operative visits for follow‑up tests and questionnaires.
- Time commitment
- The study lasts from the pre‑operative visit through at least 12 months after surgery, with several follow‑up visits to monitor recovery.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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...
- Ability to understand and the willingness to sign a written informed consent.
You likely can't join if
- people who are candidates for salvage RALP
- people on androgen deprivation therapy (ADT)
- people in whom PDE5 inhibitors are contraindicated
The study team makes the final eligibility decision.
Where it is enrolling
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New York, New York, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.