Table 5. Parameters of efficacy for Proclarix, using a threshold of 10%, regarding the characteristics of men.
Parameter | Subset 1 | Subset 2 |
---|---|---|
Sensitivity | 69/72 (95.8) | 155/158 (98.1) |
Specificity | 68/209 (32.5) | 22/128 (17.2) |
Negative predictive value | 68/71 (95.8) | 22/25 (88.0) |
Positive predictive value | 69/219 (31.5) | 155/261 (59.4) |
Correct classification | 137/281 (48.8) | 177/286 (61.9) |
Avoided magnetic resonance imaging | 71/281 (25.3) | 25/286 (8.7) |
Undetected clinically significant prostate cancer | 3/72 (4.2) | 3/158 (1.9) |
Odds ratio (95% confidence interval) | 11.092 (3.369–36.519) | 10.720 (3.130–36.735) |
p-value | <0.001 | <0.001 |
Prostate cancer detection | 117/281 (41.6) | 179/286 (62.6) |
Clinically significant prostate cancer detection | 72/281 (25.6) | 158/286 (55.2) |
Insignificant prostate cancer detection | 45/281 (16.0) | 21/286 (7.3) |
Values are presented as number (%).
Subset 1 (men with serum prostate-specific antigen 2 to 10 ng/mL, and prostate volume ≥35 mL, and normal digital rectal examination), and Subset 2 (men who do not meet any of the previous characteristics).