Table 1.
Parameter | Patients, n | Median, IQR | T2:ERG score, rs | p value | PCA3 score, rs | p value | MiPS model risk, rs | p value |
---|---|---|---|---|---|---|---|---|
Age, yr | 1225 | 64 (58-70) | 0.10 | 0.0004 | 0.32 | < 0.0001 | 0.32 | <0.0001 |
Serum PSA | 1225 | 4.7 (3.3-6.5) | 0.07 | 0.01 | 0.11 | < 0.0001 | 0.33 | <0.0001 |
Ultrasound volume, ml | 1181 | 48 (35-68) | −0.02 | 0.55 | −0.08 | 0.006 | 0.00 | 0.90 |
PSAD | 1181 | 0.091 (0.057-0.140) | 0.08 | 0.008 | 0.17 | < 0.0001 | 0.32 | <0.0001 |
PCPTrc risk, % | 1166 | 40 (33-51) | 0.09 | 0.002 | 0.16 | < 0.0001 | 0.32 | <0.0001 |
PCPTrc high-grade risk, % | 1218 | 11 (6-18) | 0.09 | 0.001 | 0.25 | < 0.0001 | 0.40 | <0.0001 |
Bx cores, positive, no. | 518 | 3 (1-5) | 0.24 | <0.0001 | 0.24 | < 0.0001 | 0.34 | <0.0001 |
Bx cores, positive, % | 518 | 25 (8-42) | 0.23 | <0.0001 | 0.23 | < 0.0001 | 0.34 | <0.0001 |
Greatest involvement of a single bx core, % | 201 | 38 (17-64) | 0.27 | 0.0001 | 0.03 | 0.67 | 0.25 | 0.0003 |
Parameter | Total patients, n | Patients, n (%) | T2:ERG score, median (IQR) | p value | PCA3 score, median (IQR) | p value | MiPS model risk, median (IQR) | p value |
---|---|---|---|---|---|---|---|---|
Diagnosis | 1225 | |||||||
Noncancer | 707 (58) | 2 (0-14) | <0.0001 | 15 (8-36) | <0.0001 | 30 (17-50) | <0.0001 | |
Cancer | 518 (42) | 15 (1-71) | 40 (19-84) | 60 (38-76) | ||||
Diagnosis | 707 | |||||||
Atypia and/or HGPIN | 269 (38) | 6 (0.5-25) | <0.0001 | 26 (12-57) | <0.0001 | 43 (26-63) | <0.0001 | |
Other benign | 438 (62) | 1 (0-7) | 12 (6-26) | 24 (14-39) | ||||
Race | 1222 | |||||||
White | 890 (73) | 5 (0.1-35) | 0.07 | 26 (11-58) | 0.002 | 42 (23-67) | 0.01 | |
Not white | 332 (27) | 4 (0-25) | 21 (8-50) | 38 (19-62) | ||||
Family History | 1170 | |||||||
Negative | 940 (80) | 4 (0.1-33) | 0.44 | 23 (10-55) | 0.23 | 39 (21-65) | 0.10 | |
Positive | 230 (20) | 6 (0.3-28) | 28 (11-61) | 46 (24-67) | ||||
DRE | 1223 | |||||||
Normal | 936 (77) | 5 (0.2-31) | 0.40 | 24 (10-54) | 0.22 | 42 (23-66) | 0.17 | |
Abnormal | 287 (23) | 5 (0-35) | 27 (10-58) | 37 (20-65) | ||||
Previous biopsy | 1223 | |||||||
No | 977 (80) | 5 (0.1-33) | 0.25 | 24 (10-57) | 0.51 | 40 (21-66) | 0.21 | |
Yes | 246 (20) | 4 (0-31) | 24 (12-53) | 43 (25-65) | ||||
Bx cores (#) | 773 | |||||||
<12 | 11 (1) | 6 (0.5-70) | 0.96 | 39 (17-68) | 0.98 | 62 (50-79) | 0.28 | |
12 | 687 (89) | 7 (0.3-48) | 32 (15-73) | 50 (30-71) | ||||
>12 | 75 (10) | 6 (0.2-94) | 32 (16-76) | 44 (32-75) | ||||
Bx Gleason score | 518 | |||||||
6 | 294 (57) | 11 (0.7-52) | 0.008 | 34 (16-75) | 0.0006 | 53 (32-72) | <0.0001 | |
>6 | 224 (43) | 23 (2-113) | 50 (23-94) | 67 (46-81) | ||||
Clinical stage | 517 | |||||||
T1 | 382 (74) | 16 (1-68) | 0.81 | 37 (19-78) | 0.17 | 59 (39-76) | 0.92 | |
>T1 | 135 (26) | 12 (0.4-95) | 47 (20-95) | 59 (35-77) | ||||
Bx signficance1 | 195 | |||||||
Insignificant | 32 (16) | 5 (0.3-29) | 0.24 | 34 (15-55) | 0.008 | 44 (28-66) | 0.007 | |
Significant | 163 (84) | 15 (0.4-70) | 50 (23-96) | 63 (42-78) | ||||
Bx significance (pathology)2 | 201 | |||||||
Insignificant | 65 (32) | 5 (0.3-29) | 0.004 | 36 (16-71) | 0.002 | 45 (28-64) | <0.0001 | |
Significant | 136 (68) | 22 (1-97) | 55 (28-103) | 68 (45-82) |
Bx = biopsy; bx = previous biopsy; DRE = digital rectal examination; HGPIN = high-grade prostatic intraepithelial neoplasia; IQR = interquartile range; MiPS = Mi-Prostate Score, serum PSA plus T2:ERG plus PCA3; PCPTrc = Prostate Cancer Prevention Trial risk calculator; PSA = prostate-specific antigen; T2:ERG, TMPRSS2:ERG.
For all evaluable patients in the validation cohort, the number of patients with data for each parameter, the median (and interquartile range), and correlations (Spearman's rho [rs]) and p values with urine T2:ERG score, urine PCA3 score, and the urine T2:ERG score plus urine PCA3 score plus serum PSA (MiPS) logistic regression model (logit) for predicting the presence of prostate cancer on biopsy are given in the upper panel. In the lower panel, the total number of patients with data for each parameter, the number (and percentage) of patients within each categorical parameter, and the median T2:ERG score, PCA3 score, and MiPS model (logit*100) and p value for each categorical comparison (Mann-Whitney or Kruskal-Walis test) are given.
Any clinical stage higher than T1c, PSA density (serum PSA/prostate volume on ultrasound) ≥0.15 ng/ml/ml, Gleason score >6, ≥25% cores positive, or >50% greatest single core Involvement as significant.
Any Gleason score >6, ≥25% cores positive, or >50% greatest single core involvement as significant.