Results from a phase 3 clinical trial, recently published in The Lancet Oncology, present a significant breakthrough in the field of prostate cancer surgery. The NeuroSAFE technique, a novel approach that allows surgeons to avoid the periprostatic neurovascular bundles during a prostate excision, has shown remarkable success. This technique not only significantly reduces the risk of incontinence but also offers a high likelihood of regaining erectile function following recovery. The advancements in robot surgical techniques have further enhanced the precision and accuracy of these procedures, leading to a more successful outcome.
The study establishes NeuroSAFE as an effective alternative to the surgical procedure commonly used to remove the prostate of prostate cancer patients, robot-assisted radical prostatectomy (RARP). The researchers compared prostate excision using standard RARP to the NeuroSAFE technique. NeuroSAFE is a novel approach in which healthcare professionals analyze sections of tissue in real-time to determine positive margins and maximize the chances of preserving the nerves. Unlike standard RARP, which attempts nerve-sparing through preoperative planning, NeuroSAFE-guided RARP uses intraoperative assessment to avoid nerve damage. This real-time analysis allows for immediate adjustments during the surgery, leading to better outcomes for the patient.
The clinical trial (NCT03317990), called NeuroSAFE PROOF, enrolled patients from five hospitals in the United Kingdom and included 381 patients who underwent surgery. Eligible patients had non-metastatic prostate cancer, good erectile function, and had not received previous treatment. In addition, patients enrolled in the trial presented as good candidates for RARP. The researchers randomized the participants to either standard RARP or NeuroSAFE-guided RARP. The doctors did not inform the patients which procedure they received but told them their nerve-sparing status after the surgery.
The researchers evaluated erectile function one year after the procedure. One year following surgery, patients in the NeuroSAFE group had significantly improved erectile function compared to those in the standard RARF group. In addition, the study compared urinary continence three and six months after the surgery. The analysis revealed significantly lower urinary continence scores, indicating better outcomes, in the NeuroSAFE than the standard RARF group. However, urinary continence scores had normalized by six months between the two groups.
Reassuringly, the study found that serious adverse events occurred similarly between treatment groups, reported in only about 3% of patients. This underscores the safety and reliability of the NeuroSAFE technique.
The trial's findings provide compelling evidence for the effectiveness of the NeuroSAFE technique in reducing erectile dysfunction and short-term urinary incontinence following prostate cancer surgery.
Sources: Lancet Oncol, J Endourol, Adv Radiat Oncol, BMJ Open
