Results:
The study included 1171 subjects. The study group included 450 patients for whom 4K ® tests were performed during April-July 2020 whereas the control group included 721 patients for whom tests were performed during April-July 2019. The age range was between 41 and 86 years and the mean age was similar between the two groups (66 versus 67 years in the study and control groups, respectively, p=0.535). The mean PSA level was similar between the two groups (7, p=0.865) – Table 1.
Table 2 shows 4K ® scores divided using 7.5%, 20% and 33% cut-offs , dividing patients to low-risk (≤7.5%) ,moderate-risk (7.5%<4K ® score ≤20%), high-risk (>20%) and very high-risk (>33%). As could be seen, a higher percentage of patients in the study group had a 4K ® score >20% indicating a high risk for clinically significant prostate cancer [146/450 (32.4%) versus 195/721 (27%), respectively, p=0.048]. Similarly, a very high risk of malignancy with 4K ® of 33% or more, was found to be significantly more common in the study group [80/450 (18%) versus 93/721 (13%), p=0.022). On the other hand, there was no significant difference between the study group and the control group regarding low-risk range [164/450 (36.4%) versus 279/721 (39%) respectively, P>0.1).
When examining the results distributed by age groups – 65 years or younger and older than 65 (table 3), we can see that there was a significant difference between the study group and the control group in patients 65 years old and younger using 4K ® scores of 20% [68 (32.2%) versus 43 (16.6%), respectively, p<0.05] and 33% [35 (16.6%) versus 13 (5%), respectively, p<0.05]. on the other hand, there was no significant difference between the groups in patients older than 65 using 4K ® scores of 20% and 33% [45 (18.8%) versus 80 (17.3%), respectively, p=0.62].