Is it possible to join a national multi-center clinical trial during cyberattack?

Background: In October 2023, our hospital encountered a major cyberattack resulting in temporary loss of institutional electronic medical record (EMR) and networks. However, we opened PATRON trial (ClinicalTrials.gov NCT # 04557501) to determine if PSMA PET/CT guided intensification of therapy is superior to standard of care (SOC) for high-risk prostate cancer. Hypotheses: It is possible to join a national multi-center phase III trial during cyberattack. Methods: An interprofessional team worked closely to screen patients and obtain informed consents. Patients randomized into the PET arm were subsequently referred to the closest cancer facility to have PSMA-PET scan (2-hour drive each way). All clinical data were documented in paper-based format and entered into EMR after the hospital recovered from the cyberattack. Results: During 3 months, 21 patients were screened, 10 eligible for the PATRON trial, and 5 signed consents. Two were randomized to have PET scans. One had no metastasis on PET and received SOC, along with 3 patients in control arm. The other patient had PET finding of oligometastases in one single lymph node and received same SOC plus 14Gy boost. As a comparison, a total of 794 patients in Canada were recruited from 19 institutions during 3.5 years. Our institution’s quarterly recruiting rate was much higher than the national average (5 vs 3.2). Conclusions: Cyberattacks are potentially catastrophic especially in cancer patients enrolled in clinical trials. Our institutional experience suggested that collaboration with another cancer center nearby could successfully enroll eligible patients into a large multi-center phase III trial.