Table 1:
Characteristics of discovery and validation cohorts.
| Discovery Cohort1 (n=610 biopsies) | Validation Cohort2 (n=922 biopsies) | |
|---|---|---|
| Age at Biopsy (median, IQR) | 64 (59 – 68) | 65 (60 – 69) |
| Body Mass Index (kg/m2) (median, IQR) | 27.2 (25.1 – 30.0) | 27.2 (25.0 – 30.6) |
| Prostate volume (cc) (median, IQR) | 40.4 (30.3 – 57.3) | 46.3 (32.5 – 62.2) |
| PSA (ng/mL) (median, IQR) | 4.5 (3.0 – 6.3) | 5.2 (3.6 – 7.3) |
| Biopsy Type (n, %) | ||
| Confirmatory Biopsy | 298 (49%) | 463 (50%) |
| Second Surveillance Biopsy | 218 (36%) | 285 (31%) |
| Third Surveillance Biopsy | 67 (11%) | 110 (12%) |
| Fourth Surveillance Biopsy | 18 (3%) | 42 (5%) |
| Fifth Surveillance Biopsy | 9 (1%) | 12 (1%) |
| Sixth Surveillance Biopsy | 0 | 7 (1%) |
| Seventh Surveillance Biopsy | 0 | 3 (<1%) |
| Prior Biopsy with 20% or more cores positive (n, %) | 132 (22%) | 240 (26%) |
| 2+ Prior Negative Biopsies (n, %) | 55 (9%) | 60 (7%) |
| Prostate Health Index (median, IQR) | 35.7 (27.4 – 49.6) | 34.0 (24.7 – 46.8) |
1
Comprised of 513 men.
2
Comprised of 629 men and includes 821 randomly sampled biopsies and 101 biopsies purposefully sampled for presence of GG2 disease.