CONTINUING A NATIONAL RANDOMIZED MULTI-CENTRE PHASE III TRIAL DURING A MAJOR CYBERATTACK ON RADIATION ONCOLOGY DEPARTMENT

We are one of the 19 cancer institutions in Canada that participated on PATRON trial (ClinicalTrials.gov NCT #04557501). The primary objective is to determine if PSMA PET/CT guided intensification of therapy is superior to standard of care (SOC) therapy as measured by improved failure-free survival in patients at high risk of advanced prostate cancer. In October 2023, our hospital encountered a major cyberattack resulting in temporary loss of institutional electronic medical record (EMR) and networks. Radiation treatment (RT) delivery was suspended for several weeks. The purpose of this work is to describe our local experience of continuing a national randomized multi-centre Phase III trial during Code Grey. An interprofessional team consisting of radiation oncologists, registered nurses, medical physicists, radiation therapists, and clinical research associates worked closely to screen prostate cancer patients, introduce PATRON, obtain informed consents, randomize patients using Castor’s decentralized clinical trial platform, start androgen deprivation therapy (ADT) if appropriate, perform CT simulation and quality assurance verification, and finally complete treatment planning and delivery before the deadline required by the study protocol. 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 PET imaging and reports passed online central review. Physical examination and PSA tests were conducted before and after treatment as outlined in the protocol. All clinical data were documented in paper-based format and entered into EMR after the hospital recovered from the cyberattack. From October 10, 2023 to January 9, 2024, a total of 21 patients were screened at the new patient referral office, 10 were potentially eligible for the PATRON trial, and 5 of them signed consent and were randomized. The cohort’s median age was 75 years (65-83), PSA at registration 28.4 (15.3–74.4), Gleason score 7 (7–8), CAPRA score 7 (6–9). Two were randomized to have PET scans. One had no metastasis on PET and received ADT, whole pelvis RT 46 Gy/23 and prostate boost 32 Gy/16 (total 78 Gy/39). The other had PET finding of oligometastases in one single pelvic lymph node and received same SOC plus boost to this node 14 Gy/7 (total dose 60 Gy/30). Three patients in the control arm received SOC without PET, including two patients by the above SOC RT with ADT and one patient by RT to prostate alone 78 Gy/39 without ADT. All 5 patients tolerated RT without significant complications. The most recent post-treatment PSA median was 0.11 (undetectable–2.0). As a comparison, a total of 796 patients in Canada were recruited from 19 institutions during 3.5 years till the end to accrual date. Our institution’s quarterly recruiting rate was much higher than the national average (5 versus 3.4). Cyberattacks on health care systems are unpredictable and potentially catastrophic especially in the cancer patients enrolled in clinical trials. Our institutional experience suggested that collaboration with another cancer centre nearby could successfully enroll eligible patients into a large multi-centre Phase III trial. The collaboration should be developed well ahead of such attack on radiation oncology facilities. An interprofessional team should work closely to alleviate the negative impact of cyberattacks and decrease potential delays in randomization, planning and delivery of RT for clinical trial patients.

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