Salvage open radical prostatectomy for recurrent prostate cancer following MRI-guided transurethral ultrasound ablation (TULSA) of the prostate: feasibility and efficacy

Abstract

Introduction: MRI-guided transurethral ultrasound ablation (TULSA) is a novel modality for minimally invasive ablation in patients with localised prostate cancer (PCa). A multi-national Phase 1 (30 patients) and subsequent Phase 2 (115 patients) study showed TULSA to be feasible, safe and well tolerated. However, technical viability and safety of salvage prostatectomy for those who failed TULSA is unclear. Herein, we report the feasibility and morbidity of salvage radical prostatectomy (sRP) post-TULSA.

Methods: Four patients with biopsy-proven residual cancer following TULSA underwent open retropubic sRP within 39 months of TULSA. Peri-and post-operative morbidity were reported. Detailed histopathologic assessment is reported.

Results: Median follow-up was 43 months after sRP. Mean operating times, blood loss, and length of stay were 210 min, 866 ml, and 3.5 days, respectively. Intraoperative finding of some fibrotic reaction of endopelvic and Denonvilliers fascia was characteristic. There were no perioperative complications. Whole-mount pathology sections showed one pT2b and three pT3a, suggesting under-staging pre-TULSA. Location of disease was compatible with persistent cancer mostly in the untreated peripheral safety region. One man received an artificial urinary sphincter. All men experienced erectile dysfunction responsive to treatment. Two patients with positive surgical margins had PSA progression requiring salvage radiation, with one requiring long-term androgen deprivation therapy.

Conclusions: RP is a viable and safe salvage option if TULSA fails. Technical difficulty and perioperative morbidity were negligible and attributable to minimal peri-prostatic reaction from TULSA.

Keywords:

• Salvage prostatectomy
• MRI guided
• TULSA
• localised prostate cancer

Acknowledgements

Profound Medical Inc. approved the manuscript.

Research involving human subjects and informed consent

The Phase I clinical trial was approved by local ethics boards as well as registered in USA (NCT01686958) and Europe, (DRKS00005311). Informed consent was obtained from all participating individuals.

Disclosure statement

Joseph L. Chin certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (e.g. employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Joseph L. Chin is a consultant for Profound Medical Inc. Shiva M Nair received honorarium for participating in a user feasibility study for Profound Medical Inc. The remaining authors have nothing to disclose.