One of the biggest challenges in managing aggressive and locally advanced prostate cancer is how best to balance the competing goals of achieving cancer control with maintaining continence and sexual function patients. Ash Tewari, MBBS, MCh, FRCS (Hon.), Chair of the Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai, has found a solution he believes is safe, practicable, and easily replicated.
Dr. Tewari has developed saline-assisted fascial engorgement (SAFE), an innovative technique he is using 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.
“Research has shown that the extent of neural preservation and the use of an atraumatic and traction-free dissection can significantly improve functional results,” says Dr. Tewari, who is also Surgeon-in-Chief of the Tisch Cancer Hospital that is to open in 2027.
“Our technique facilitates atraumatic dissection of the multilayer periprostatic fascia by promoting the visualization of the neurovascular hammock. That visualization enables us to determine the extent to which the nerves are engulfed in cancer and save the nerves vital to sexual function and continence without leaving any cancer cells.”
Dr. Tewari confirmed the efficacy and benefits of the technique in a retrospective study that compared outcomes among Mount Sinai patients who underwent RALP with SAFE (33) against those among patients who underwent RALP (66) alone between January 2020 and July 2022. The SAFE technique was performed using both a transperitoneal approach that Dr. Tewari has been testing and a transrectal approach guided by micro-ultrasound. The study in BJU International was published online in December 2023.
Included patients had a baseline Sexual Health Inventory for Men (SHIM) score of ≥17 and a high risk of extracapsular extension (21 percent to 73 percent) who were planned to have a Grade 3 nerve-sparing approach. The primary outcome was erectile function, with potency defined as a SHIM score of ≥17 and the secondary outcome, continence, was defined as no pads per day. To ensure comparability between the groups, Dr. Tewari conducted a propensity score matching analysis using a 1:2 ratio.
Dr. Tewari observed significant differences in the SHIM among the two study cohorts at follow-up intervals of 6, 13, 26, and 52 weeks, with the results favoring the RALP + SAFE (P = 0.01, P < 0.001, P < 0.001, and P = 0.01, respectively). These results remained significant when the mean SHIM score was assessed. He found that erectile function rates were higher in the RALP + SAFE cohort compared to the RALP alone cohort (log-rank P < 0.001). The baseline SHIM and use of the SAFE technique were independent predictors of erectile function recovery.
“It is notable that the potency rates we achieved through the SAFE technique are similar to those documented in the literature for cases of maximal bilateral nerve preservation at 13, 26, and 52 weeks after surgery,” Dr. Tewari says. “These similarities may be a reflection of the nontraumatic nature of the SAFE approach.”
Dr. Tewari says the SAFE technique does not lengthen the procedure or increase complications. In fact, when combined with intraoperative micro-ultrasound, it results in enhanced oncological safety when dissecting the fascia layers among patients with a high risk of extracapsular extension.
“All the patients who underwent the transrectal approach with SAFE achieved negative surgical margins,” he says. “Those outcomes were likely facilitated by the ability to conduct a real-time evaluation of the relationship between the tumor and the prostate capsule using the micro-ultrasound.”
Given the study’s small sample size and retrospective nature, Dr. Tewari says prospective, randomized trials are required to validate his findings. A prospective, randomized clinical trial is underway that is actively enrolling patients, with 30 already enrolled. However, he believes the merits of the technique have been demonstrated through the results he has achieved.
“It is a practical, safe, and easy technique to implement in clinical practice that facilitates atraumatic dissection of the neural hammock and visualization of the periprostatic nerves,” he says.