Objective: To investigate the safety and cancer control of a novel bioabsorbable, low-dose rate brachytherapy device, CivaSheet® (CivaTech Oncology Inc., Durham, NC, USA), in combination with radical prostatectomy (RP) with or without adjuvant external beam radiation therapy (EBRT) for the management of prostate cancer (PCa).

Methods: This is an initial, single-centre experience, two-dose level, two-stage study conducted on patients with intermediate- and high-risk PCa. The CivaSheet was implanted during RP, followed by adjuvant EBRT in patients with adverse pathological features. Toxicities and peri- and postoperative complications were assessed. Biochemical recurrence (BCR) at the 6-month follow-up after EBRT was also evaluated.

Results: Six patients were enrolled, with a median (range) age of 56 (53-71) years. No intraoperative complications occurred. No dose-limiting toxicities were observed at a maximum tested dose of 75 Gy. BCR occurred in one patient at 6 months, while another patient had residual disease and metastasis at 6 months. All patients reported having postoperative erectile dysfunction and one patient experienced urinary incontinence after EBRT.

Conclusions: This study demonstrated the feasibility and safety of CivaSheet combined with RP and adjuvant EBRT for high-risk PCa. The short-term toxicity profile was well-tolerated, supporting further prospective evaluation with clinical trials.