Methods
This is a retrospective cohort study evaluating the results of 4K ® score tests performed in Israel before and during the COVID-19 pandemic.
Institutional ethical approval was obtained. The Data was obtained and collected anonymously from the Bioreference Laboratories which performs the 4K scores in Israel; As this is the only one lab in Israel responsible for 4K tests, the numbers and results represent the entire tests performed in Israel in a given period. As the data is retrospective and anonymous some details are missing such as family history of prostate cancer, findings on digital rectal examination, previous TURS-guided biopsies and the results and PSA kinetics
The study group was defined as males who completed the 4K ® score tests between April 1st 2020 and July 31th 2020 during the first quarantine period in Israel. The control group was defined as males who completed the tests during April-July 2019, before the COVID-19 pandemic. Clinical and demographic data were compared between the groups. Multivariate analyses were used to define factors independently associated with 4K® scores indicating increased risk for malignancy.
The primary outcome was defined as the percentage of patients with a 4K ® score above 20% indicating an increased risk for a clinically significant prostate cancer [4]. Secondary outcomes were the percentages of patients with 4K ® scores indicating a low-risk and a very high-risk for clinically significant prostate cancers (<7.5% and >33%, respectively).
The database was obtained from Bioreference Laboratories, which performs the tests in Israel. The bilateral value of 0.05 was defined as statistically significant. All statistical analyses were performed using IPSS software version 25.
The study was approved by local Helsinki committee. As the study is retrospective and does not identify patients, a waiver of informed consent was granted by the ethical committee.