Resect SAFE study: providing a reliable impression of the positive surgical margin in patients undergoing robot assisted radical prostatectomy for prostate cancer

In Europe, prostate cancer is the most prevalent malignancy among males aged 50
and above. Robot-assisted radical prostatectomy (RARP) represents the favored
therapeutic approach for patients with localized prostate cancer. The primary
objective of this procedure is the complete excision of all prostate cancer
tissue. When evaluating the outcomes of this surgical intervention, a
persistent high positive surgical margin (PSM) rate becomes evident. Across
various studies, approximately 30% of patients undergoing RARP exhibit a
positive surgical margin in the pathology specimen. Furthermore, diverse
investigations demonstrate that patients with a positive surgical margin
experience inferior oncological outcomes, as indicated by postoperative
biochemical recurrence.

Consequently, the imperative arises to mitigate the incidence of positive
surgical margins. Our supposition is that achieving this objective is
attainable through surgical refinement of the procedure, involving the excision
of abundant tissue at locations where, based on the positioning of the
prostatic tumor, a positive surgical margin is anticipated. The occurrence of a
positive surgical margin is expected in regions characterized by a higher
number of prostate biopsies yielding cancer diagnosis and/or at sites where the
prostatic tumor is discernible on the diagnostic preoperative magnetic
resonance imaging (MRI) scan. The resection of abundant tissue surrounding the
prostate can potentially lead to the removal of a greater extent of prostate
cancer tissue, consequently contributing to a reduced positive surgical margin
rate.

The primary objective of this study is to reduce the incidence of positive
surgical margins in patients undergoing RARP by conducting an intraoperative
excision of abundant peri-prostatic tissue.

Secondary endpoints include the number of complications arising from the
excision of abundant peri-prostatic tissue and the percentage of biochemical
recurrence at 6 months and 1 year.

It is a prospective monocenter observational cohort study, with the inclusion
of patients undergoing RARP at the Antoni van Leeuwenhoek Hospital. The study
duration extends for a period of 12 months.

During the prostatectomy, subsequent to the prostate removal and achieving
satisfactory hemostasis, abundant tissue is excised on the non-nerve-sparing
side(s) surrounding the area previously occupied by the prostate, as well as at
the location of the neurovascular bundle.

Very low risk (<<5%) of postoperative bleeding or injury to the rectum.