Feasibility of in-office MRI-targeted partial gland cryoablation for prostate cancer: an IDEAL stage 2A study

BMJ Surg Interv Health Technol. 2020 Nov 18;2(1):e000056. doi: 10.1136/bmjsit-2020-000056. eCollection 2020.

Abstract

Objectives: Cryoablation for prostate cancer is typically performed under general anaesthesia. We explore the safety, feasibility and costs of in-office MRI-targeted prostate partial gland cryoablation (PGC) under local anaesthesia. We hypothesise that an office-based procedure under local anaesthesia may yield greater patient convenience and lower health costs with similar outcomes to a general anaesthesia approach.

Design/participants/setting/interventions: Retrospective study of men diagnosed with clinically significant prostate cancer (grade group (GG) ≥2) who elected to undergo in-office PGC under local anaesthesia.

Main outcome measures: A total of 55 men with GG ≥2 prostate cancer underwent PGC under local anaesthesia, and 35 of 43 men (81.4%) who attained ≥6 months of follow-up post-treatment underwent MRI-targeted surveillance biopsy. We used MRI findings and targeted biopsy to characterise post-PGC oncological outcomes. Complications were categorised using Common Terminology Criteria for Adverse Events (CTCAE). Expanded Prostate Cancer Index-Clinical Practice was used to characterise urinary and sexual function scores at baseline, 4 and 9 months post-PGC. Time-driven activity-based costing was used to determine healthcare costs of in-office PGC.

Results: Five (9.1%) men experienced CTCAE score 3 adverse events. Urinary and sexual function did not change significantly from baseline to 4 months (p=0.20 and p=0.08, respectively) and 9 months (p=0.23 and p=0.67, respectively). Twenty-two men (62.9%) had no cancer or GG1 and 13 (37.1%) men had GG≥2 on post-PGC biopsy. Moreover, the median cost of in-office PGC was US$4,463.05 (range US$4,087.19-US7,238.16) with disposables comprising 69% of the cost.

Conclusions: In-office PGC is feasible under local anaesthesia with favourable functional outcome preservation and adverse events profile at significantly lower costs compared with a general anaesthesia approach.

Keywords: devices; exploration study; outcomes research; urology devices.