Table 4 Clinical use population compared to validation cohort.

From: Clinical use of the mRNA urinary biomarker SelectMDx test for prostate cancer

 

Clinical use population

Validation cohort Haese [4]

P value

N

5 157

916

 

Age median, years (Q1–Q3)

65 (60–71)

65 (60–70)

0.465, a

PSA median, ng/mL (Q1–Q3)

6.6 (4.90–9.06)

6.37 (4.50–9.20)

0.067, a

PV median, cm3 (Q1–Q3)b

50 (38–70)

42.5 (30.9–60.0)

<0.001*, a,b

PSA density median, ng/ml2 (Q1–Q3)

0.126 (0.09–0.19)

0.140 (0.09–0.22)

<0.001*, a,b

DRE abnormal/normal/unknown (%)

919 (17.82)/4 238 (82.18)/0 (0)

204 (22.28)/706 (77.07)/6 (0.66)

0.001*, c,d

PSA < 3 ng/ml, N (%)

275 (5.33)

80 (8.73)

<0.001*, c

PSA ≥ 3 & ≤10 ng/ml, N (%)

3 953 (76.65)

640 (69.87)

<0.001*, c

PSA above 10 ng/ml, N (%)

929 (18.01)

196 (21.40)

0.015*, c

SelectMDx result: positive, N (%); negative, N (%);

3 057 (59.28)/2 100 (40.72)

589 (64.30)/327 (35.70)

0.004*, c

  1. *Significant difference (p < 0.05) between both groups.
  2. aMann–Whitney U Test.
  3. bProstate volume and therefore PSA density unknown for 94 patients in the clinical use population and for 9 patients in the validation cohort Haese [4].
  4. cPearson Chi-Square Test.
  5. d6 cases from validation cohort excluded, because DRE outcome was unknown.
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